Apparatus and method for measuring biologic parameters

ABSTRACT

Support structures for positioning sensors on a physiologic tunnel for measuring physical, chemical and biological parameters of the body and to produce an action according to the measured value of the parameters. The support structure includes a sensor fitted on the support structures using a special geometry for acquiring continuous and undisturbed data on the physiology of the body. Signals are transmitted to a remote station by wireless transmission such as by electromagnetic waves, radio waves, infrared, sound and the like or by being reported locally by audio or visual transmission. The physical and chemical parameters include brain function, metabolic function, hydrodynamic function, hydration status, levels of chemical compounds in the blood, and the like. The support structure includes patches, clips, eyeglasses, head mounted gear and the like, containing passive or active sensors positioned at the end of the tunnel with sensing systems positioned on and accessing a physiologic tunnel.

This application claims priority from and the benefit of U.S.Provisional Application Ser. No. 60/374,133, filed on Apr. 22, 2002.

FIELD OF THE INVENTION

The present invention includes support and sensing structures positionedin a physiologic tunnel for measuring bodily functions and to manageabnormal conditions indicated by the measurements.

BACKGROUND OF THE INVENTION

Interfering constituents and variables can introduce significant sourceof errors that prevent measured biologic parameters from being ofclinical value. In order to bypass said interfering constituents andachieve undisturbed signals invasive and semi-invasive techniques havebeen used. Such techniques have many drawbacks including difficulties inproviding continuous monitoring for long periods of time. Non-invasivetechniques also failed to deliver the clinical usefulness needed. Theplacement of a sensor on the skin characterized by the presence ofinterfering constituents do not allow obtaining clinically useful noraccurate signals due to the presence of said interfering constituentsand background noise which greatly exceeds the signal related to thephysiologic parameter being measured.

The most precise, accurate, and clinically useful way of evaluatingthermal status of the body in humans and animals is by measuring braintemperature. Brain temperature measurement is the key and universalindicator of both disease and health equally, and is the only vital signthat cannot be artificially changed by emotional states. The other vitalsigns (heart rate, blood pressure, and respiratory rate) all can beinfluenced and artificially changed by emotional states or voluntaryeffort.

Body temperature is determined by the temperature of blood, which emitsheat as far-infrared radiation. Adipose tissue (fat tissue) absorbsfar-infrared and the body is virtually completely protected with a layerof adipose tissue adherent to the skin. Thus measurement of temperatureusing the skin does not achieve precision nor accuracy because previoustechniques using sensors placed on skin included by the presence ofadipose tissue.

Because it appeared to be impossible with current technology tonon-invasively measure brain temperature, attempts were made todetermine internal body temperature, also referred to as coretemperature. An invasive, artificial, inconvenient, and costly processis currently used to measure internal (core) temperature consisting ofinserting a catheter with a temperature sensor in the urinary canal,rectum or esophagus. But such methodology is not suitable for routinemeasurement, it is painful, and has potential fatal complications.

Semi-invasive techniques have also being tried. Abreu disclosed in U.S.Pat. No. 6,120,460 apparatus and methods for measuring core temperaturecontinuously using a contact lens in the eyelid pocket, but the contactlens is a semi-invasive device which requires prescription by aphysician and sometimes it is not easy to place the contact lens in theeye of an infant or even in adults and many people are afraid oftouching their eyes.

There are several drawbacks and limitations in the prior art forcontinuous and/or core measurement of temperature.

Measurement of temperature today is non-continuous, non-core and nursedependent. Nurses have to stick a thermometer in the patient's mouth,rectum or ear. To get core temperature nurses invasively place a tubeinside the body which can cause infection and costly complications.

Measurement of core temperature on a routine basis in the hospitaland/or continuously is very difficult and risky because it requires aninvasive procedure with insertion of tubes inside the body or byingesting a thermometer pill. The thermometer pill can cause diarrhea,measure temperature of the fluid/food ingested and not body temperature,and have fatal complications if the pill obstructs the pancreas or liverducts. Placement of sensors on the skin do not provide clinically usefulmeasurements because of the presence of many interfering constituentsincluding fat tissue.

It is not possible to acquire precise and clinically useful measurementsof not only brain temperature, but also metabolic parameters, physicalparameters, chemical parameters, and the like by simply placing a sensoron the skin. One key element is the presence of fat tissue. Fat variesfrom person to person, fat varies with aging, fat content varies fromtime to time in the same person, fat attenuates a signal coming from ablood vessel, fat absorbs heat, fat prevents delivery of undisturbedfar-infrared radiation, fat increases the distance traveled by theelement being measured inside the body and an external sensor placed onthe surface of the skin.

There is a need to identify a method and apparatus that cannon-invasively, conveniently and continuously monitor brain temperaturein a painless, simple, external and safe manner with sensors placed onthe skin.

There is further a need to identify a method and apparatus that canconveniently, non-invasively, safely and precisely monitor biologicalparameters including metabolic parameters, physical parameters, chemicalparameters, and the like.

There is a need to identify an apparatus and method capable of measuringbiological parameters by positioning a sensor on a physiologic tunnelfor the acquisition of undisturbed and continuous biological signals.

SUMMARY OF THE INVENTION

The present invention provides methods, apparatus and systems thateffectively address the needs of the prior art.

In general, the invention provides a set of sensing systems andreporting means which may be used individually or in combination, whichare designed to access a physiologic tunnel to measure biological,physical and chemical parameters. Anatomically and physiologicallyspeaking, the tunnel discovered by the present invention is an anatomicpath which conveys undisturbed physiologic signals to the exterior. Thetunnel consists of a direct and undisturbed connection between thesource of the function (signal) within the body and an external point atthe end of the tunnel located on the skin. A physiologic tunnel conveyscontinuous and integral data on the physiology of the body. Anundisturbed signal from within the body is delivered to an externalpoint at the end of the tunnel. A sensor placed on the skin at the endof the tunnel allows optimal signal acquisition without interferingconstituents and sources of error.

Included in the present invention are support structures for positioninga sensor on the skin at the end of the tunnel. The present inventiondiscloses devices directed at measuring brain temperature, brainfunction, metabolic function, hydrodynamic function, hydration status,hemodynamic function, body chemistry and the like. The componentsinclude devices and methods for evaluating biological parameters usingpatches, clips, eyeglasses, head mounted gear and the like with sensingsystems adapted to access physiologic tunnels to provide precise andclinically useful information about the physiologic status of the wearerand for enhancing the safety and performance of said wearer, and helpingto enhance and preserve the life of said wearer by providing adequatereporting means and alert means relating to the biological parameterbeing monitored. Other components provide for producing direct orindirect actions, acting on another device, or adjusting another deviceor article of manufacture based on the biological parameter measured.

The search for a better way to measure biological parameters hasresulted in long and careful research, which included the discovery of aBrain Temperature Tunnel (BTT) and other physiologic tunnels in humansand animals. The present invention was the first to recognize thephysiologic tunnel in the body. The present invention was yet the firstto recognize the end of the tunnel on the skin surface in which anoptimal signal is acquired and measurements can be done without thepresence of interfering constituents and background noise that exceedsthe signal being measured. The present invention was also the first torecognize and precisely map the special geometry and location of thetunnel including the main entry point. The present invention was yetfirst to recognize the precise positioning of sensing systems at themain entry point for optimal signal acquisition. Careful studies havebeen undertaken including software development for characterizinginfrared radiation to precisely determine the different aspects of thetunnel. This research has determined that the measurement of brain(core) temperature and other body parameters can be accomplished in anon-invasive and continuous manner in humans and animals with sensorspositioned in a confined area of the skin at the end of a physiologictunnel.

The key function and critical factor for life preservation and humanperformance is brain temperature. Brain tissue is the tissue in the bodymost susceptible to thermal damage, by both high and low temperature.Brain temperature is the most clinically relevant parameter to determinethe thermal status of the body and the human brain is responsible for 18to 20% of the heat produced in the body, which is an extraordinary factconsidering that the brain represents only 2% of the body weight. Thegreat amount of thermal energy generated in the brain is kept in aconfined space and the scalp, skull, fat and CSF (cerebral spinal fluid)form an insulating layer. The recognition of the BTT by the presentinvention bypasses the insulating barriers and provides a directconnection to inside the brain physiology and physics.

Anatomically and physiologically speaking, a Brain Temperature Tunnelconsists of a continuous, direct, and undisturbed connection between theheat source within the brain and an external point at the end of thetunnel. The physical and physiological events at one end of the tunnelinside the brain are reproduced at the opposite end on the skin. A BTTenables the integral and direct heat transfer through the tunnel withoutinterference by heat absorbing elements, i.e., elements that can absorbfar-infrared radiation transmitted as heat by blood within the brain.There are six characteristics needed to define a BTT. Thesecharacteristics are:

-   -   1) area without heat absorbing elements, i.e., the area must not        contain adipose tissue (fat tissue). This is a key and needed        characteristic for defining a temperature tunnel,    -   2) area must have a terminal branch of a vessel in order to        deliver the integral amount of heat,    -   3) terminal branch has to be a direct branch of a blood vessel        from the brain,    -   4) terminal branch has to be superficially located to avoid heat        absorption by deep structures such as muscles,    -   5) area must have a thin and negligible interface between a        sensor and the source of thermal energy to achieve high heat        flow, and    -   6) area must not have thermoregulatory arteriovenous shunts.        All six characteristics are present on the skin on the medial        canthal area adjacent to the medial corner of the eye above the        medial canthal tendon and in the medial third of the upper        eyelid. In more detail the end of BTT area on the skin measures        about 11 mm in diameter measured from the medial corner of the        eye at the medial canthal tendon and extend superiorly for about        6 mm and then extends into the upper eyelid in a horn like        projection for another 22 mm.

The BTT area is the only area in the body without adipose tissue, whichis in addition supplied by a terminal branch, which has a superficialblood vessel coming from the brain vasculature, and which has a thininterface and no thermoregulatory shunts. The BTT area is supplied by aterminal branch of the superior ophthalmic vein which is a directconnection to the cavernous sinus, said cavernous sinus being anendothelium-lined system of venous channels inside the brain whichcollects and stores thermal energy. The blood vessel supplying the BTTarea is void of thermoregulatory arteriovenous shunts and it ends on theskin adjacent to the medial corner of the eye and in the superior aspectof the medial canthal area right at the beginning of the upper eyelid.The blood vessels deliver undisturbed heat to the skin on the medialcanthal area and upper eyelid as can be seen in the color as well asblack and white photos of infrared images shown in FIGS. 1 and 2. Theundisturbed thermal radiation from the brain is delivered to the surfaceof the skin at the end of the tunnel. The heat is delivered to an areaof skin without fat located at the end of the tunnel. The blood vesseldelivering heat is located just below the skin and thus there is noabsorption of infrared radiation by deep structures.

If the blood vessel is located deep, other tissues and chemicalsubstances would absorb the heat, and that can invalidate the clinicalusefulness of the measurement. There is direct heat transfer and theskin in the BTT area is the thinnest skin in the body and is void ofthermoregulatory arteriovenous shunts. A very important aspect foroptimal measurement of temperature is no interference by fat tissue anddirect heat transfer.

The absence of fat tissue in this particular and unique area in the bodyat the end of the tunnel allows the undisturbed acquisition of thesignal. The combination of those six elements allows the undisturbed andintegral emission of infrared radiation from the brain in the form ofdirect heat transfer at the BTT area location, which can be seen in theinfrared image photographs (FIGS. 1 to 8). The BTT and physiologictunnels are also referred in this description as the “Target Area”.

From a physical standpoint, the BTT is the equivalent of a Brain ThermalEnergy tunnel with high total radiant power and high heat flow. Thetemperature of the brain is determined by the balance between thermalenergy produced due to metabolic rate plus the thermal energy deliveredby the arterial supply to the brain minus the heat that is removed bycerebral blood flow. Convection of heat between tissue and capillariesis high and the temperature of the cerebral venous blood is inequilibrium with cerebral tissue. Accordingly, parenchymal temperatureand thermal energy of the brain can be evaluated by measuring thetemperature and thermal energy of the cerebral venous blood. Thesuperior ophthalmic vein has a direct and undisturbed connection to thecavernous sinus and carries cerebral venous blood with a thermal energycapacity of 3.6 J·ml⁻¹·(° C.)⁻¹ at hematocrit of 45%. Cerebralthermodynamic response, thermal energy, and brain temperature can beevaluated by placing a sensor to capture thermal energy conveyed by thecerebral venous blood at the end of the BTT.

The research concerning BTT and physiologic tunnels involved variousactivities and studies including: 1) In-vitro histologic analysis ofmucosal and superficial body areas; 2) In-vivo studies with temperatureevaluation of external areas in humans and animals; 3) In-vivofunctional angiographic evaluation of heat source; 4) Morphologicstudies of the histomorphometric features of the BTT area; 5) In-vivoevaluation of temperature in the BTT area using: thermocouples,thermistors, and far-infrared; 6) Comparison of the BTT areameasurements with the internal eye anatomy and current standard mostused (oral) for temperature measurement; 7) Cold and heat challenge todetermine temperature stability of BTT; and 8) Infrared imaging andisotherm determination. Software for evaluating geometry of tunnel wasalso developed and used. Simultaneous measurement of a referencetemperature and temperature in the BTT area were done using pre-equallycalibrated thermistors. A specific circuit with multiple channels wasdesigned for the experiments and data collection.

The measurement of temperature in the BTT area showed almost identicaltemperature signal between the BTT area and the internal conjunctivalanatomy of the eye, which is a continuation of the central nervoussystem. Measurement of the temperature in the internal conjunctivalanatomy of eye as used in the experiment was described by Abreu in U.S.Pat. Nos. 6,120,460 and 6,312,393. The averaged temperature levels forBTT and internal eye were within 0.1° C. (0.18° F.) with an averagenormothermia value equivalent of 37.1° C. (98.8° F.) for the BTT and 37°C. (98.6° F.) for the internal eye. Comparison with the standard mostused, oral temperature, was also performed. The temperature voltagesignal of the BTT area showed an average higher temperature level in theBTT area of an equivalent of 0.3° C. (0.5° F.) when compared to oral.

Subjects underwent cold challenge and heat challenge through exercisingand heat room. The lowering and rising of temperature in the BTT areawas proportional to the lowering and rising in the oral cavity. However,the rate of temperature change was faster in the BTT area than for oralby about 1.2 minutes, and temperature at the BTT site was 0.5° C. (0.9°F.) higher on few occasions. Subjects of different race, gender, and agewere evaluated to determine the precise location of the BTT area acrossa different population and identify any anatomic variation. The locationof the BTT was present at the same location in all subjects with nosignificant anatomic variation, which can be seen in a sample ofinfrared imaging of different subjects.

The tunnel is located in a crowded anatomic area and thus thepositioning of the sensor requires special geometry for optimalalignment with the end of the tunnel. The clinical usefulness of thetunnel can only be achieved with the special positioning of the sensorin relation to anatomic landmarks and the support structure. The tunnelis located in a unique position with distinctive anatomic landmarks thathelp define the external geometry and location of the end of the tunnel.The main entry point of the tunnel, which is the preferred location forpositioning the sensor, requires the sensor to be preferably placed inthe outer edge of a support structure. The preferred embodiment for themeasurement of biological parameters by accessing a physiologic tunnelincludes sensors positioned in a particular geometric position on thesupport structure.

The support structure includes patches containing sensors. For thepurpose of the description any structure containing an adhesive as meansto secure said structure to the skin at the end of the tunnel isreferred to as a patch including strips with adhesive surfaces such as a“BAND-AID” adhesive bandage. It is understood that a variety ofattachment means can be used including adhesives, designs incorporatingspring tension pressure attachment, and designs based on otherattachment methods such as elastic, rubber, jelly-pads and the like.

The patches are adapted to position sensors at the end of the tunnel foroptimal acquisition of the signal. The patch is preferably secured tothe area by having an adhesive backing which lays against the skin,although a combination of adhesive and other means for creating a stableapposition of the sensor to the tunnel can be used such as fastening orpressure.

Support structures also include clips or structures that are positionedat the end of the tunnel with or without adhesive and which are securedto the area by pressure means. Any structure that uses pressure means tosecure said structure to the skin at the end of the tunnel is referredas a clip.

Head-mounted structures are structures mounted on the head or neck forpositioning sensors on the end of the tunnel and include head bands withaccessories that are adjacent to the tunnel, visors, helmets, headphone,structures wrapping around the ear and the like. For the purpose of thisdescription TempAlert is referred herein as a system that measurestemperature in the BTT area and has means to report the measured valueand that can incorporate alarm means that are activated when certainlevels are reached. Support structures yet include any article that hassensing means in which said sensing means are positioned at the end ofthe tunnel.

Support structures further include medial canthal pieces of eyeglasses.A medial canthal piece is also referred to herein as a medial canthalpad and includes a pad or a piece which positions sensing means on theskin at the medial canthal area on top of a tunnel, with said medialcanthal piece being permanently attached to or mounted to an eyeglass.Any sensing means incorporated in an eyeglass (fixed or removable) foraccessing a tunnel are referred to herein as EyEXT including means forsensing physical and chemical parameters. Any article of manufacturethat has visual function, or ocular protection, or face protection witha part in contact with the tunnel is referred herein as eyeglasses andincludes conventional eyeglasses, prescription eyeglasses, readingglasses, sunglasses, goggles of any type, masks (including gas masks,surgical masks, cloth masks, diving masks, eyemask for sleeping and thelike) safety glasses, and the like.

For brain temperature evaluation the tunnel area consists of the medialcanthal area and the superior aspect of the medial corner of the eye.For brain function evaluation the tunnel area consists of primarily theupper eyelid area. For metabolic function evaluation the tunnel areaconsists of an area adjacent to the medial corner of the eye and boththe upper and lower eyelids.

The measurement of metabolic function, brain function, immunogenicfunction, physical parameters, physico-chemical parameters and the likeincludes a variety of support structures with sensors accessing thephysiologic tunnels. The sensors are placed in apposition to the skinimmediately adjacent to the medial corner of the eye preferably in thesuperior aspect of the medial canthal area. The sensor can also bepositioned in the medial third of the upper eyelid. The sensor is mostpreferably located at the main entry point of the tunnel which islocated on the skin 2.5 mm medial to the corner of the eye and about 3mm above the medial corner of the eye. The diameter of the main entrypoint is about 6 to 7 mm. The positioning of the sensor at the mainentry point of the tunnel provides the optimum site for measuringphysical and chemical parameters of the body.

Besides a sensor that makes contact with the skin at the Target Area, itis understood that sensors which do not make contact with the skin canbe equally used. For instance an infrared-based temperature measuringsystem can be used. The measurement is based on the Stefan-Boltzman lawof physics in which the total radiation is proportional to the fourthpower of the absolute temperature, and the Wien Displacement law inwhich the product of the peak wavelength and the temperature areconstant. The field of view of the non-contact infrared apparatus of theinvention is adapted to match the size and geometry of the BTT area onthe skin.

A variety of lenses known in the art can be used for achieving the fieldof view needed for the application. For example, but not by way oflimitation, a thermopile can be adapted and positioned in a manner tohave a field of view aimed at the main entry point of the BTT area onthe skin. The signal is then amplified, converted into a voltage outputand digitized by a MCU (microcontroller).

This infrared-based system can be integrated into a support structurethat is in contact with the body such as any of the support structuresof the present invention. In addition, it is understood that theinfrared-based system of the present invention can be integrated as aportable or hand-held unit completely disconnected from the body. Theapparatus of the present invention can be held by an operator that aimssaid apparatus at the BTT area to perform the measurement. The apparatusfurther includes an extension shaped to be comfortably positioned at theBTT site for measuring biological parameters without discomfort to thesubject. The extension in contact with the skin at the BTT is shaped inaccordance with the anatomic landmarks and the geometry and size of theBTT site. The infrared radiation sensor is positioned in the extensionin contact with the skin for receiving radiation emitted from the BTTsite.

The present invention provides a method for measuring biologicalparameters including the steps of positioning sensing means on the skinarea at the end of a tunnel, producing a signal corresponding to thebiological parameter measured and reporting the value of the parametermeasured.

It is also included a method to measure biological parameters bynon-contact infrared thermometry comprising the steps of positioning aninfrared detector at the BTT site with a field of view that encompassesthe BTT site and producing a signal corresponding to the measuredinfrared radiation. The biological parameters include temperature, bloodchemistry, metabolic function and the like.

Temperature and ability to do chemical analysis of blood components isproportional to blood perfusion. The present invention recognizes thatthe tunnel area, herein also referred as a Target Area, has the highestsuperficial blood perfusion in the head and has a direct communicationwith the brain, and that the blood vessels are direct branches of thecerebral vasculature and void of thermoregulatory arteriovenous shunts.It was also recognized that the Target Area has the highest temperaturein the surface of the body as can be seen in the photographs ofexperiments measuring infrared emission from the body and the eye.

The Target Area discovered not only has the thinnest and mosthomogeneous skin in the whole body but is the only skin area without afat layer. Since fat absorbs significant amounts of radiation, there isa significant reduction of signal. Furthermore other skin areas onlyprovide imprecise and inaccurate signals because of the large variationof adipose tissue from person to person and also great variability offat tissue according to age. This interference by a fat layer does notoccur in the Target Area. Furthermore, the combined characteristics ofthe Target Area, contrary to the skin in the rest of the body, enablethe acquisition of accurate signals and a good signal to noise ratiowhich far exceeds background noise. In addition, body temperature suchas is found in the surface of the skin in other parts of the body isvariable according to the environment.

Another important discovery of the present invention was thedemonstration that the Target Area is not affected by changes in theenvironment (experiments included cold and heat challenge). The TargetArea provides an optimum location for temperature measurement which hasa stable temperature and which is resistant to ambient conditions. TheTarget Area discovered has a direct connection to the brain, is notaffected by the environment and provides a natural, complete thermalseal and stable core temperature. The apparatus and methods of thepresent invention achieve precision and clinical usefulness needed withthe non-invasive placement of a temperature sensor on the skin in directcontact with the heat source from the brain without the interference ofheat absorbing elements.

The Target Area is extremely vascularized and is the only skin area inwhich a direct branch of the cerebral vasculature is superficiallylocated and covered by a thin skin without a fat layer. The main trunkof the terminal branch of the ophthalmic vein is located right at theBTT area and just above the medial canthal tendon supplied by the medialpalpebral artery and medial orbital vein. The BTT area on the skinsupplied by a terminal and superficial blood vessel ending in aparticular area without fat and void of thermoregulatory arteriovenousshunts provides a superficial source of undisturbed biological signalsincluding brain temperature, metabolic function, physical signals, andbody chemistry such as glucose level, and the like.

Infrared spectroscopy is a technique based on the absorption of infraredradiation by substances with the identification of said substancesaccording to its unique molecular oscillatory pattern depicted asspecific resonance absorption peaks in the infrared region of theelectromagnetic spectrum. Each chemical substance absorbs infraredradiation in a unique manner and has its own unique absorption spectradepending on its atomic and molecular arrangement and vibrational androtational oscillatory pattern. This unique absorption spectra allowseach chemical substance to basically have its own infrared spectrum,also referred to as fingerprint or signature which can be used toidentify each of such substances. Radiation containing various infraredwavelengths is emitted at the substance to be measured and the amount ofabsorption of radiation is dependent upon the concentration of saidchemical substance being measured according to Beer-Lambert's Law.

Interfering constituents and variables such as fat, bone, muscle,ligaments and cartilage introduce significant source of errors which areparticularly critical since the background noise greatly exceeds thesignal of the substance of interest. Since those interferingconstituents area not present on the skin at the BTT area, the sensingsystems positioned at said BTT are can acquire optimal signal withminimal noise including spectroscopic-based measurements.

Spectroscopic means integrated into support structures disclosed in thepresent invention can precisely non-invasively measure blood componentssince the main sources of variation and error, such as fat tissue, arenot present in the Target Area. In addition, other key constituentswhich interfere with electromagnetic energy emission such as muscle,cartilage and bones, are not present in the Target Area either. Theblood vessels delivering the infrared radiation are superficiallylocated and the infrared radiation is delivered at the end of the tunnelwithout interacting with other structures. The only structure to betraversed by the infrared radiation is a very thin skin, which does notabsorb the infrared wavelength. The present invention includes infraredspectroscopy means to provide a clinically useful measurement with theprecise and accurate determination of the concentration of the bloodcomponents at the end of the tunnel.

In addition to spectroscopy in which electromagnetic energy is deliveredto the Target Area, the present invention also discloses apparatus andmethods for measuring substances of interest through far infraredthermal emission from the Target Area. Yet, besides near-infraredspectroscopy and thermal emission, other means are disclosed formeasurement of substances of interest at the Target Area includingelectroosmosis as a flux enhancement by iontophoresis or reverseiontophoresis with increased passage of fluid through the skin throughapplication of electrical energy. Yet, transcutaneous optical means canalso be integrated into support structures including medial canthalpieces, modified nose pads, and the frame of eyeglasses, with said meanspositioned to access the tunnel.

It is understood that application of current, ultrasonic waves as wellas chemical enhancers of flow, electroporation and other means can beused to increase permeation at the tunnel site such as for exampleincreased flow of glucose with the use of alkali salts. In additioncreating micro holes in the target area with a laser, or other meansthat penetrate the skin can be done with the subsequent placement ofsensing means on the BTT site, with said means capable of measuringchemical compounds.

Furthermore, reservoirs mounted on or disposed within supportstructures, such as the frame and pads of eyeglasses, can deliversubstances transdermally at the BTT site by various means includingiontophoresis, sonophoresis, electrocompression, electroporation,chemical or physical permeation enhancers, hydrostatic pressure and thelike.

In addition to measure the actual amount of oxygen in blood, the presentinvention also discloses means to measure oxygen saturation and theamount of oxygenated hemoglobin. In this embodiment the medial canthalpiece of a support structure or the modified nose pads of eyeglassescontain LEDs emitting at two wave lengths around 940 and 660 nanometers.As the blood oxygenation changes, the ratio of the light transmitted bythe two frequencies changes indicating the oxygen saturation. Since theblood level is measured at the end of a physiologic brain tunnel, theamount of oxygenated hemoglobin in the arterial blood of the brain ismeasured, which is the most valuable and key parameter for athleticpurposes and health monitoring.

The present invention also provides a method for measuring biologicalparameters with said method including the steps of directingelectromagnetic radiation at the BTT area on the skin, producing asignal corresponding to the resulting radiation and converting thesignal into a value of the biological parameter measured.

Besides using passive radio transmission or communication by cable;active radio transmission with active transmitters containing amicrominiature battery mounted in the support structure can also beused. Passive transmitters act from energy supplied to it from anexternal source. The transensor transmits signals to remote locationsusing different frequencies indicative of the levels of biologicalparameters. Ultrasonic micro-circuits can also be mounted in the supportstructure and modulated by sensors which are capable of detectingchemical and physical changes at the Target Area. The signal may betransmitted using modulated sound signals particularly under waterbecause sound is less attenuated by water than are radio waves.

One preferred embodiment comprises a support structure including a patchadapted to be worn on or attached with adhesives to the tunnel andincludes structural support, a sensor for measuring biologicalparameters, power source, microcontroller and transmitter. The parts canbe incorporated into one system or work as individual units. The sensoris located preferably within 7 mm from the outer edge of the patch. Theapparatus of the invention can include a temperature sensor located inthe outer edge of the patch for sensing temperature. The transmitter,power source and other components can be of any size and can be placedin any part of the patch or can be connected to the patch as long as thesensing part is placed on the edge of the patch in accordance with theprinciples of the invention. The sensor in the patch is positioned onthe skin adjacent to the medial canthal area (medial corner of the eye)and located about 2 mm from the medial canthal tendon. The sensor canpreferably include electrically-based sensors, but non-electricalsystems can be used such as chemicals that respond to changes intemperature including mylar.

Besides patches, another preferred embodiment for measuring biologicalparameters at the physiologic tunnel includes a medial canthal pad. Themedial canthal piece is a specialized structure containing sensors foraccessing the tunnel and adapted to be worn on or attached to eyeglassesin apposition to the tunnel and includes structural support, a sensorfor measuring biological parameters, power source, microcontroller andtransmitter. The parts can be incorporated into one system or work asindividual units. The sensors are positioned on the BTT area. Thetransmitter, power source, and other components can be placed in themedial canthal pad or in any part of the eyeglasses. A medial canthalpiece or extension of nose pads of eyeglasses allow accessing thephysiologic tunnel with sensing devices laying in apposition to the BTTarea.

The apparatus of the invention include a temperature sensor located inthe medial canthal pad. For temperature measurement the sensing systemis located on a skin area that includes the medial canthal corner of theeye and upper eyelid. The sensor in the medial canthal pad is preferablypositioned on the skin adjacent to the medial canthal area (medialcorner of the eye). Although one of the preferred embodiments formeasurement of brain temperature consists of medial canthal pads, it isunderstood that also included in the scope of the invention are nosepads of a geometry and size that reach the tunnel and that are equippedwith temperature sensors preferably in the outer edge of said nose padsfor measuring brain temperature and other functions. An oversized andmodified nose pad containing sensors using a special geometry foradequate positioning at the BTT area is also included in the invention.

With the disclosure of the present invention and by using anatomiclandmarks in accordance with the invention the sensor can be preciselypositioned on the skin at the end of the tunnel. However, since there isno external visible indication on the skin relating to the size orgeometry of the tunnel, accessory means can be used to visualize, map ormeasure the end of the tunnel on the skin. These accessory means may beparticularly useful for fitting medial canthal pads or modified nosepads of eyeglasses.

Accordingly, a infrared detector using thermocouple or thermopiles canbe used as an accessory for identifying the point of maximum thermalemission and to map the area. An infrared imaging system or thermographymeans may be preferably used. In this instance, an optical store sellingthe eyeglasses can have a thermal imaging system. The optician,technician and the like take an infrared image picture or film the area,and in real time localize the tunnel of the particular user. The medialcanthal pads or modified nose pads can then be adjusted to fit theparticular user based on the thermal infrared imaging. The eyeglassesare fitted based on the thermal image created. This will allowcustomized fitting according to the individual needs of the user. Anythermography-based system can be used including some with great visualimpact and resolution as a tri-dimensional color thermal wave imaging.

It is also a feature of the invention to provide a method to be used forexample in optical stores for locating the tunnel including the steps ofmeasuring thermal infrared emission, producing an image based on theinfrared emission, and detecting the area with the highest amount ofinfrared emission. Another step that can be included is adjustingsensors in support structures to match the area of highest infraredemission.

One of said support structures includes the medial canthal pieces ornose pads of eyeglasses. The thermal imaging method can be used forfitting a patch, but said patch can be positioned at the tunnel byhaving an external indicator for lining up said indicator with apermanent anatomic landmark such as the medial corner of the eye.Although medial canthal pieces of eyeglasses can have an externalindicator for precise positioning, since opticians are used to fiteyeglasses according to the anatomy of the user, the thermal imagingmethod can be a better fit for eyeglasses than an external indicator onthe medial canthal pieces or modified nose pads of eyeglasses.

The source of the signal is key for the clinical usefulness of themeasurement. The brain is the key and universal indicator of the healthstatus of the body. The signal coming from the brain or brain areaprovides the most clinically useful data. In accordance with anotherembodiment, the measurement of biological parameters will be described.The amount of sodium and other elements in sweat is a key factor forsafety and performance of athletes and military, as well as healthmonitoring.

For instance hyponatremia (decreased amount of sodium) can lead toreduced performance and even death. Hyponatremia can occur due to excesswater intake, commonly occurring with intense physical activity andmilitary training. Sweat can be considered as an ultrafiltrate of blood.The blood vessels supplying the skin on the head are branches of thecentral nervous system vasculature. The amount of chemical substancespresent in the sweat coming from those blood vessels is indicative ofthe amount of chemical substances present in the cerebral vasculature.For instance, sodium concentration of sweat from blood vessels in thehead changes in relation to the rates of sweating. The apparatus andmethods of the present invention can prevent death or harm due to waterintoxication, by providing alert signals when the levels of sodium insweat reach a certain threshold for that particular wearer. The presenceof various chemical elements, gases, electrolytes and pH of sweat andthe surface of the skin can be determined by the use of suitableelectrodes and suitable sensors integrated in the eyeglasses and othersupport structures mounted on the head or fitted on the head or face.These electrodes, preferably microelectrodes, can be sensitized byseveral reacting chemicals which are in the sweat or the surface of theskin. The different chemicals and substances can diffuse throughsuitable permeable membranes sensitizing suitable sensors.

For example but not by way of limitation, electrochemical sensors can beused to measure various analytes such as glucose using a glucose oxidasesensor and the pilocarpine iontophoresis method can be used to measureelectrolytes in sweat alone or in conjunction with microfluidics system.Besides the support structures of the present invention, it is alsounderstood that other articles such as watches, clothing, footwear andthe like can be adapted to measure concentration of substances such aselectrolytes present in sweat, however there is reduced clinicalrelevance for evaluating metabolic state of an individual outside thecentral nervous system.

Body abnormalities may cause a change in the pH, osmolarity, andtemperature of the sweat derived from brain and neck blood vessels aswell as change in the concentration of substances such as acid-lactic,glucose, lipids, hormones, gases, markers, infectious agents, antigens,antibody, enzymes, electrolytes such as sodium, potassium and chloride,and the like. Eyeglasses and any head gear can be adapted to measure theconcentration of substances in sweat. Microminiature glass electrodesmounted in the end portion of the temple of eyeglasses sitting behindthe ear or alternatively mounted on the lens rim against the foreheadcan be used to detect divalent cations such as calcium, as well assodium and potassium ion and pH. Chloride-ion detectors can be used todetect the salt concentration in the sweat and the surface of the skin.

Many agents including biological warfare agents and HIV virus arepresent in sweat and could be detected with the eyeglasses or supportstructure on the head or face using sensors coated with antibodiesagainst the agent which can create a photochemical reaction withappearance of colorimetric reaction and/or potential shift withsubsequent change in voltage or temperature that can be detected andtransmitted to a monitoring station or reported locally by audio orvisual means. Electrocatalytic antibodies also can generate anelectrical signal when there is an antigen-antibody interaction. It isalso understood that other articles such as watches, clothing, footwear,and the like or any article capturing sweat can be adapted to identifyantigens, antibody, infectious agents, markers (cancer, heart, genetic,metabolic, drugs, and the like) in accordance with the presentinvention. However, identification of those elements away from thecentral nervous system is of reduced clinical relevance.

The different amounts of fluid encountered in sweat can be easilyquantified and the concentration of substances calibrated according tothe amount of fluid in sweat. The relationship between the concentrationof chemical substances and molecules in the blood and the amount of saidchemical substances in the sweat can be described mathematically andprogrammed in a computer.

The present invention also includes eyeglasses or support structures inwhich a radio frequency transensor capable of measuring the negativeresistance of nerve fibers is mounted in the eyeglasses or supportstructure. By measuring the electrical resistance, the effects ofmicroorganisms, drugs, and poisons can be detected. The system alsocomprises eyeglasses in which a microminiature radiation-sensitivetransensor is mounted in said eyeglasses or support structure.

The brain has a rich vasculature and receives about 15% of the restingcardiac output and due to the absence of fat the tunnel offers an areafor optimal signal acquisition for evaluating hemodynamics. Accordingly,change in the viscosity of blood can be evaluated from a change indamping on a vibrating quartz micro-crystal mounted in the eyeglasses orsupport structure and the invention can be adapted to measure bloodpressure and to provide instantaneous and continuous monitoring of bloodpressure through an intact wall of a blood vessel from the brain and toevaluate hemodynamics and hydrodynamics. Also, by providing a contactmicrophone, arterial pressure can be measured using sonic means.

Pressure can be applied to a blood vessel through a micro cuff mountedin the medial canthal pads, or alternatively by the temples ofeyeglasses. Pressure can also be applied by a rigid structure, and thepreferred end point is reached when sound related to blood turbulence isgenerated. The characteristic sound of systole (contraction of theheart) and diastole (relaxation of the heart) can be captured by themicrophone. A microphone integrated into the medial canthal pad can beadapted to identify the heart sounds. Pressure transducers such as acapacitive pressure transducer with integral electronics for signalprocessing and a microphone can be incorporated in the same siliconstructure and can be mounted in the medial canthal pad. Motion sensorsand/or pressure sensors can be mounted in the medial canthal pad tomeasure pulse.

Reversible mechanical expansion methods, photometric, or electrochemicalmethods and electrodes can be mounted in the eyeglasses or supportstructures of the present invention and used to detect acidity, gases,analyte concentration, and the like. Oxygen gas can also be evaluatedaccording to its magnetic properties or be analyzed bymicro-polarographic sensors mounted in the eyeglasses or other supportstructure. A microminiature microphone mounted in the eyeglasses orother support structure can also be adapted to detect sounds from theheart, respiration, flow, vocal and the environment, which can be sensedand transmitted to a remote receiver or reported by local audio andvisual means. The sensors are adapted and positioned to monitor thebiological parameters at the end of the tunnel.

The eyeglasses or other support structures can also have elements whichproduce and radiate recognizable signals and this procedure could beused to locate and track individuals, particularly in militaryoperations. A permanent magnet can also be mounted in the eyeglasses andused for tracking as described above. A fixed frequency transmitter canbe mounted in the eyeglasses and used as a tracking device whichutilizes a satellite tracking system by noting the frequency receivedfrom the fixed frequency transmitter to a passing satellite, or viaGlobal Positioning Systems. Motion and deceleration can be detected bymounting an accelerometer in the eyeglasses. The use of eyeglasses astracking means can be useful for locating a kidnapped individual or forrescue operations in the military, since eyeglasses are normallyunsuspecting articles.

The use of integrated circuits and advances occurring in transducer,power source, and signal processing technology allow for extrememiniaturization of the components which permits several sensors to bemounted in one unit.

The present invention provides continuous automated brain temperaturemonitoring without the need for a nurse. The present invention canidentify a spike in temperature. Thus, proper diagnosis is made andtherapy started in a timely fashion. Time is critical for identifyingthe temperature spike and organism causing the infection. Delay inidentifying spike and starting therapy for the infection can lead todemise of the patient. The invention timely and automatically identifiesthe temperature spike and prevents the occurrence of complications.

The present invention also alerts the user about overheating orhypothermia to allow:

-   -   1. Proper hydration;    -   2. Increased performance;    -   3. Increased safety; and    -   4. Feed back control in treadmills and other exercise machines        for keeping proper hydration and performance.

Annually many athletes, construction workers, college students and thegeneral public unnecessarily die due to heatstrokes. Once the brainreaches a certain temperature level such as 40° C., an almostirreversible process ensues. Because there are no specific symptoms andafter a certain point there is rapid increase in brain temperature,heatstroke has one of the highest fatality rates. The more severe andmore prolonged the episode, the worse the predicted outcome, especiallywhen cooling is delayed. Without measuring core temperature and havingan alert system when the temperature falls outside safe levels it isimpossible to prevent hyperthermia and heatstroke. The present inventionprovides means for continuous monitoring of temperature with alertsystems that can prevent dangerous levels to be reached and coolingmeasures applied if needed. The apparatus can be adapted to be used inan unobtrusive manner by athletes, military, workers and the generalpopulation.

All chemical reactions in the body are dependent on temperature. Hightemperature can lead to enzymatic changes and protein denaturation andlow temperature can slow down vital chemical reactions. Hydration isdependent on brain temperature and loss of fluid leads to a rise inbrain temperature. Minimal fluctuations in the body's temperature canadversely affect performance and increase risk of illness and of lifethreatening events. Therefore, it is essential that athletes, sportsparticipants, military personnel, police officers, firefighters, forestrangers, factory workers, farmers, construction workers and otherprofessionals have precise means to know exactly what is their braintemperature.

When the core temperature rises, the blood that would otherwise beavailable for the muscles is used for cooling via respiration andperspiration. The body will do this automatically as temperature movesout of the preferred narrow range. It is this blood shifting thatultimately impairs physical performance and thermal induced damage tobrain tissue interferes with normal cognitive function. Intense exercisecan increase heat production in muscles 20 fold. In order to preventhyperthermia and death by heat stroke athletes drink water. Because theingestion of water is done in a random fashion, many times there iswater intoxication which can lead to death as occurs to many healthypeople including marathon runners and military personnel. Both, excessof water (overhydration) or lack of water (dehydration) can lead tofatal events besides reducing performance. Therefore, it is essentialthat individuals have precise means to know exactly when and how much todrink. By monitoring brain temperature with the present invention properhydration can be achieved and athletes and military will know preciselywhen and how much water to ingest.

Timely ingestion of fluids according to the core temperature allowsoptimization of cardiovascular function and avoidance of heat strain.Because there is a delay from the time of ingestion of fluid toabsorption of said fluid by the body, the method of invention includessignaling the need for ingestion at a lower core temperature such as38.5° C. to account for that delay, and thus avoid the onset ofexhaustion. The temperature threshold can be adjusted according to eachindividual, the physical activity, and the ambient temperature.

In addition, software can be produced based on data acquired at the BTTsite for optimizing fitness, athletic performance, and safety. The uppertemperature limit of a particular athlete for maintaining optimalperformance can be identified, and the data used to create software toguide said athlete during a competition. For instance, the athlete canbe informed on the need to drink cold fluid to prevent reaching acertain temperature level which was identified as reduced performancefor said athlete. Brain temperature level for optimal performanceidentified can be used to guide the effort of an athlete duringcompetition and training. Hyperthermia also affects mental performanceand software based on data from the BTT can be produced to optimizemental and physical performance of firefighters in an individual manner.People can have different thresholds for deleterious effects ofhyperthermia and thus setting one level for all users may lead tounderutilization of one's capabilities and putting others at risk ofreduced performance. Likewise, exercise endurance and mental performanceis markedly reduced by hypothermia and the same settings can be appliedfor low temperature situations. Determinations of brain temperature,oxygen and lactic acid levels can also be used for endurance training ofathletes, fitness training, and to monitor the effects of training. Thesystem, method, and apparatus of the invention provides means forenhancing safety and optimizing fitness for athletes and recreationalsports participants.

It is a feature of the invention to provide a method for the precise andtimely intake of fluids including the steps of measuring braintemperature, reporting the signal measured, and ingesting an amount offluid based on the signal measured. Other steps can be included such asreporting means using voice reproduction or visual means to instruct onwhat beverage to drink and how much to drink to reduce core temperature.It is understood that the method of the present invention can combinemeasurement of temperature associated with measurement of sodium insweat or blood, in accordance with the principles of the invention.

Children do not tolerate heat as well as adults because their bodiesgenerate more heat relative to their size than adults do. Children arealso not as quick to adjust to changes in temperatures. In addition,children have more skin surface relative to their body size which meansthey lose more water through evaporation from the skin. It is understoodthat different sizes, shapes, and designs of medial canthal padsincluding children size can be used in the present invention. Childreneyeglasses equipped with sensors can have a booster radio transmitterthat will transmit the signal to a remote receiver and alert parentsabout dangerous temperature levels. The eyeglasses can be incorporatedwith a detecting system to send a signal if the eyeglasses were removedor if the temperature sensor is not capturing signals in a propermanner. By way of illustration, but not of limitation, pressure sensingmeans can be incorporated in the end of the temples to detect if thesunglasses are being worn, and an abrupt drop in the pressure signalindicates glasses were removed or misplacement of the sensor can alsogenerate an identifiable signal. An adhesive, a double-sided adhesivetape, or other means for increasing grip can be used in the medialcanthal pads to assure more stable position. It is understood that theeyeglasses can come equipped with sensors to detect ambient temperatureand humidity, which allows for precisely alerting the wearer about anyaspect affecting heat conditions.

In the current industrial, nuclear and military settings, personnel maybe required to wear protective clothing. Although the protectiveclothing prevent harm by hazardous agents, the garments increase therate of heat storage. It is understood that the present invention can becoupled with garments with adjustable permeability to automatically keepthe core temperature within safe limits.

In addition, the present invention alerts an individual about risk ofthermal damage (risk of wrinkles and cancer) at the beach or duringoutdoor activities. When one is at the beach, watching a game in astadium, camping or being exposed to the sun, the radiant energy of thesun is absorbed and transformed into thermal energy. The combination ofthe different means of heat transfer to the body lead to an increase inbody temperature, which is reflected by the brain temperature.Convection and conduction can also lead to an increase in bodytemperature through heat transfer in the absence of sun light. Theabsorption of heat from the environment leads to a rise in the averagekinetic energy of the molecules with subsequent increase in coretemperature.

The levels of core temperature is related to the risk of thermal damageto the skin. After certain levels of heat there is an increased risk ofdenaturing protein and breaking of collagen in the skin. This can becompared with changes that occur when frying an egg. After a certainamount of thermal radiation is delivered the egg white changes fromfluidic and transparent to a hard and white structure. After the eggwhite reaches a certain level of temperature the structural changebecomes permanent. After a certain level of increase in core temperatureduring sun exposure, such as a level of 37.7° Celsius to 37.9° Celsiusat rest (e.g.; sun bathing), thermal damage may ensue and due to thedisruption of proteins and collagen there is an increased risk forwrinkle formation. The increased brain temperature correlates to theamount of thermal radiation absorbed by the body, and the duration ofexposure of the temperature level times the level of temperature is anindicator of the risk of thermal damage, wrinkle formation, and skincancer.

The present invention provides an alarm system that can be set up toalert in real time when it is time to avoid sun exposure in order toprevent further absorption of thermal radiation and reduce the risk ofdermatologic changes, as can occur during outdoor activities or at thebeach. In addition, thermal damage to the skin prevents the skin fromadequately cooling itself and can result in increasing the risk ofdehydration which further increases the temperature. The presentinvention helps preserve the beauty and health of people exposed to sunlight and during outdoor activities while allowing full enjoyment of thesun and the benefits of sun light.

By the present invention, a method for timing sun exposure includes thesteps of measuring body temperature, reporting the value measured andavoiding sun exposure for a certain period of time based on the levelmeasured.

Hypothermia is the number one killer in outdoor activities in the U.S.and Europe. Hypothermia also decreases athletic performance and leads toinjuries. It is very difficult to detect hypothermia because thesymptoms are completely vague such as loss of orientation and clumsinesswhich are indistinguishable from general behavior. Without measuringcore temperature and having an alert system when the temperature fallsoutside safe levels it is impossible to prevent hypothermia due to thevague symptoms. The present invention can alert an individual abouthypothermia during skiing, scuba diving, mountain climbing and hiking.The present invention provides means to precisely inform when certaintemperature thresholds are met, either too high or too low temperature.

The present invention continuously monitors the brain temperature and assoon as a temperature spike or fever occurs it activates diagnosticssystems to detect the presence of infectious agents, which can be donelocally in the BTT site, or the infectious agents can be identified inother parts of the body such as the blood stream or the eyelid pocket.The present invention can be also coupled to drug dispensing means forthe automated delivery of medications in accordance with the signalproduced at the BTT site including transcutaneous means, iontophoresisor by injection using a pump.

The invention also includes a tool for family planning. The system candetect spike and changes in basal temperature and identify moment ofovulation and phases of the menstrual cycle. This allows a woman to planpregnancy or avoid pregnancy. This eliminates the need for invasivedevices used for monitoring time for artificial insemination not onlyfor humans but also animals. The invention can yet detect the start ofuterine contractions (parturition) and allow a safer birth for animals.Support structures can be equally used in the BTT of animals.

The present invention also includes Automated Climate control accordingto the value measured at the BTT. The temperature of the user controlsthe temperature in the car. When the body starts to warm up, the signalfrom the apparatus of the invention automatically activates the airconditioner according to the user settings, alternatively it activatesheat when the body is cold. This automation allows drivers toconcentrate on the road and thus can reduce the risk for car crashes. Itis understood that other articles that can affect body temperature canbe controlled by the present invention including vehicle seats.Likewise, automated climate control at home, work, or any confined areacan be achieved by activating the thermostat directly or via BlueToothtechnology. Besides convenience and comfort, this automation allowssaving energy since gross changes manually done in the thermostat leadsto great energy expenditure.

It is understood that any body temperature measuring system can provideautomated climate control or adjust temperature of articles inaccordance with the principles of the present invention.

The present invention yet includes methods for reducing weight. Itincludes monitoring of temperature during programs for weight reductionbased on increasing body heat to reduce said weight. The system alertsathletes on a weight losing program to prevent injury or death byoverheating. The system can monitor temperature of people in sauna,steam rooms, spas and the like as part of weight reduction programs inorder to prevent injuries and enhance results.

Yet, methods to enhance memory and performance besides preserving healthby providing an automated mechanism to control ambient temperature andsurrounding body temperature based on the brain temperature measured bythe present invention. Human beings spent about one third of their livessleeping. Many changes in body temperature occur during sleep. All ofthe metabolism and enzymatic reactions in the body are dependent onadequate level of temperature. The adequate control of ambienttemperature which matches the needs of body temperature such as duringsleeping have a key effect on metabolism. Adequate ambient temperatureand surrounding temperature of objects which matches body temperatureallow not only for people to sleep better, but also to achieve improvedefficiency of enzymatic reactions which leads to improved mental abilityand improved immune response. A variety of devices such as blankets,clothing, hats, mattress, pillows, or any article touching the body orin the vicinity of the body can be adapted to automatically increase ordecrease temperature of said articles according to the temperaturesignal from the present invention.

The body naturally becomes cooler during the night and many people haverestless sleep and turn continuously in bed because of that temperatureeffect. Since the tossing and turning occurs as involuntary movementsand the person is not awake, said person cannot change the stimuli suchas for instance increasing room temperature or increasing temperature ofan electric blanket. The present invention automatically changes theambient temperature or temperature of articles to match the temperatureneeds of the person. This is particularly useful for infants, elderly,diabetics, neuro-disorders, heart disease, and a variety of otherconditions, since this population has reduced neurogenic response tochanges in body temperature, and said population could suffer moreduring the night, have increased risk of complications besides decreasedproductivity due to sleep deprivation.

The invention also provides means and methods to be used with biofeedback activities. A brain temperature signal from the sensor at theBTT site produces a feedback signal as an audio tone or visual displayindicating temperature and a series of tones or colors identify if thebrain temperature is increasing (faster frequency and red) or decreasing(lower frequency and blue). The display means can be connected by wiresto the support structure holding the sensor at the BTT site.

Head cooling does not change brain temperature. Athletes, military,firefighters, construction workers and others are at risk of heatstrokedespite pouring cold water on their head or using a fan. Medicallyspeaking that is a dangerous situation because the cool feeling sensedin the head is interpreted as internal cooling and the physical activityis maintained, when in reality the brain remains at risk of thermalinduced damage and heatstroke. Other medical challenges related totemperature disturbances concern response time. The brain has a slowerrecovery response to temperature changes than core temperature (internaltemperature measured in rectum, bladder, esophagus, and other internalmeans). Thus, internal measurement may indicate stable temperature whilethe brain temperature remains outside safe levels, with risk of induceddamage to cerebral tissue, either due to hypothermia or hyperthermia.The only medically acceptable way to prevent cerebral tissue damage dueto temperature disturbances is by continuous monitoring braintemperature as provided by the present invention.

The present invention utilizes a plurality of active or passive sensorsincorporated in support structures for accessing a physiologic tunnelfor measuring biological parameters. The present invention preferablyincludes all functions in a miniature semiconductor chip, which as anintegrated circuit, incorporates sensor, processing and transmittingunits and control circuits.

The present invention includes means for collecting thermal radiationfrom a BTT site, means for positioning temperature sensitive devices toreceive thermal radiation from the BTT site and means for convertingsaid thermal radiation into the brain temperature. The present inventionalso provides methods for determining brain temperature with saidmethods including the steps of collecting the thermal emission from theBTT site, producing a signal corresponding to the thermal emissioncollected, processing the signal and reporting the temperature level.The invention also includes means and methods for proper positioning ofthe temperature sensor in a stable position at the BTT site.

It is also an object of the present invention to provide supportstructures adapted to position a sensor on the end of a tunnel on theskin to measure biological parameters.

It is an object of the present invention to provide apparatus andmethods to measure brain (core) temperature including patches, adhesivesstrips, elastic means, clips and the like containing sensors positionedon a physiologic tunnel.

It is an object of the present invention to provide multipurposeeyeglasses equipped with medial canthal pads containing sensorspositioned on a physiologic tunnel for measuring biological parameters

It is another object of the present invention to provide new methods andapparatus for measuring at least one of brain temperature, chemicalfunction and physical function.

It is yet an object of the invention to provide apparatus that fit onboth adults and children.

It is also an object of the invention to provide apparatus that reportthe signal produced at the tunnel by at least one of wired connection toreporting means, wireless transmission to reporting means and localreporting by audio, visual or tactile means such as by vibrationincorporated in support structures.

It is yet another object of the present invention to provide apparatusthat allow the wearer to avoid dehydration or overhydration (waterintoxication).

It is a further object of the present invention to provide methods andapparatus that allows athletes and sports participants to increase theirperformance and safety.

It is yet an object of the present invention to provide supportstructure positioned sensors on a tunnel which can be worn at least byone of athletes during practice and competition, military duringtraining and combat, workers during labor and the general public duringregular activities.

It is another object of the present invention to increase safety andcomfort in vehicles by providing automated climate control and vehicleseat control based on the core temperature of the occupants of thevehicle.

It is an object of the present invention to provide methods andapparatus that act on a second device based on the level of thebiological parameter measured.

It is another object of the invention to provide methods and apparatusto preserve skin health, reduce risk of wrinkles and reduce the risk ofskin cancer by preventing sun damage by thermal radiation and alertingthe wearer when the temperature has reached certain thresholds.

It is also an object of the invention to provide methods and apparatusfor achieving controlled weight loss based on heat-based weight lossapproach.

It is also an object of the invention to provide methods and apparatusto alert athletes in a weight losing program based on increasing bodytemperature to prevent injury or death by overheating.

It is also an object of the invention to provide methods and apparatusthat allow monitoring fever and spikes of temperature.

It is also an object of the invention to provide means for familyplanning by detecting time of ovulation.

It is a further object of the invention to provide methods and apparatusfor the delivery of medications in accordance with the signal producedat the tunnel.

It is yet an object of the invention to provide methods and apparatusthat enhance occupational safety by continually monitoring biologicalparameters.

It is also an object of the invention to provide an article ofmanufacture with a sensing apparatus positioned on a tunnel formonitoring biological parameters that can be fitted or mounted in atleast one of the frame of eyeglasses, the nose pads of eyeglasses, thestructure of a head mounted gear and clothing.

The invention also features transmitting the signal from the supportstructure to act on at least one of exercise equipment, bikes, sportsgear, protective clothing, footwear and medical devices.

It is yet an object of the invention to provide support structures thattransmit the signal produced at the tunnel to treadmills and otherexercise machines for keeping proper hydration and preventingtemperature disturbances of the user.

It is yet another object of the invention to provide apparatus andmethods for monitoring biological parameters by accessing a physiologictunnel using active or passive devices.

The invention yet features transmission of the signal from the supportstructures to watches, pagers, cell phones, computers, and the like.

These and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description taken in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a thermal infrared image of the human face showing the braintemperature tunnel.

FIG. 1B is a computer generated thermal infrared color image of thehuman face showing the brain temperature tunnel.

FIG. 2A is a schematic diagram showing a physiologic tunnel.

FIG. 2B is a cross-sectional schematic diagram of the human head showingthe tunnel.

FIG. 2C is a coronal section schematic diagram showing the cavernoussinus of FIG. 2B.

FIG. 3A is a thermal infrared image of the human face showing thetunnel.

FIG. 3B is a schematic diagram of the image in FIG. 3A showing thegeometry at the end of the tunnel.

FIG. 4A is a thermal infrared image of the side of the human faceshowing a general view of the main entry point of the brain temperaturetunnel.

FIG. 4B is a schematic diagram of the image in FIG. 4A.

FIG. 5A is a thermal infrared image of the front of the human faceshowing the main entry point of the brain temperature tunnel.

FIG. 5B is a schematic diagram of the image in FIG. 5A.

FIG. 5C is a thermal infrared image of the side of the human face inFIG. 5A showing the main entry point of the brain temperature tunnel.

FIG. 5D is a schematic view of the image in FIG. 5C.

FIG. 6 is a schematic view of the face showing the general area of themain entry point of the tunnel and peripheral parts.

FIG. 6A is a schematic diagram showing the brain temperature tunnel andthe metabolic tunnel.

FIGS. 7A and 7B are thermal infrared images of the human face before andafter cold challenge.

FIGS. 8A and 8B are thermal infrared images of the human face ofdifferent subjects showing the tunnel.

FIGS. 9A and 9B are thermal infrared images of animals showing a tunnel.

FIG. 10 is a perspective view of a preferred embodiment showing a personwearing a support structure comprised of a patch with a passive sensorpositioned on the skin at the end of the tunnel in accordance with thepresent invention.

FIG. 11 is a perspective view of another preferred embodiment showing aperson wearing a support structure comprised of a patch with a passivesensor positioned on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 12A is a front perspective view of a person wearing a supportstructure comprised of a patch with an active sensor positioned on theskin at the end of the tunnel in accordance with the present invention.

FIG. 12B is a side schematic view showing the flexible nature of thesupport structure shown in FIG. 12A.

FIG. 13 is a schematic block diagram of one preferred embodiment.

FIG. 14 is a schematic diagram of one preferred embodiment of theinvention interacting with devices and articles of manufacture.

FIGS. 15A to 15E are schematic views showing preferred embodiments ofthe invention using indicators.

FIGS. 16A to 16C are perspective views of a preferred embodiment showinga person wearing support structures incorporated as patches.

FIG. 17 is a perspective view of another preferred embodiment showing aperson wearing a support structure incorporated as a clip with a sensorpositioned on the skin at the end of the tunnel in accordance with thepresent invention.

FIG. 18 is a perspective view of another preferred embodiment showing aperson wearing a support structure with a sensor positioned on the skinat the end of the tunnel and connected by a wire.

FIGS. 19A1, 19A2, 19B, 19C and 19D are schematic diagrams of preferredgeometry and dimensions of support structures and sensing means

FIGS. 20A to 20C are schematic diagrams of preferred dimensions of theouter edge of support structures in relation to the outer edge ofsensing means.

FIGS. 21A and 21B are schematic diagrams of preferred positions ofsensing means.

FIGS. 22A to 22C are perspective views of preferred embodiments showinga person wearing a support structure incorporated as a medial canthalpad with a sensor positioned on the skin at the end of the tunnel inaccordance with the present invention.

FIGS. 23A and 23B are perspective views of an alternative embodimentshowing a support structure comprised of modified nose pads with asensor positioned on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 24 is a perspective view of another preferred embodiment of supportstructure in accordance with the invention.

FIG. 25 is a perspective view of one preferred embodiment of supportstructure showing additional means for including a sensor.

FIG. 26A is a rear perspective view of one preferred embodiment of asupport structure with display means.

FIG. 26B is a front perspective view of one preferred embodiment of asupport structure with display means.

FIG. 27 is an exploded perspective view of another preferred embodimentshowing a three piece support structure.

FIG. 28A is an exploded perspective view of one preferred embodiment ofsupport structure showing a removable medial canthal piece.

FIG. 28B is a rear perspective view of the removable medial canthalpiece of FIG. 28A.

FIG. 28C is a front perspective view of the removable medial canthalpiece of FIG. 28B.

FIG. 29 is a rear perspective view of one preferred embodiment of asupport structure incorporated as a clip-on for eyeglasses.

FIG. 30 is a perspective view of one alternative embodiment of a supportstructure with medial canthal pads that uses an adhesive backing forsecuring to another structure.

FIG. 31A is a top perspective view of one alternative embodiment of asupport structure with holes for securing medial canthal pads.

FIG. 31B is a magnified perspective view of part of the supportstructure of FIG. 31A.

FIG. 31C is a side perspective view of part of the support structure ofFIG. 31B.

FIG. 31D is a side perspective view of a medial canthal piece secured atthe support structure.

FIG. 32A is a perspective view of a person wearing a support structurecomprised of medial canthal caps secured on top of a regular nose pad ofeyeglasses.

FIG. 32B is a perspective view of the medial canthal cap of FIG. 32A.

FIG. 33A is an exploded perspective view of a medial canthal cap beingsecured to the nose pad.

FIG. 33B is a perspective view of the end result of the medial canthalcap secured to the nose pad.

FIG. 34 is a perspective view of a modified rotatable nose pad toposition a sensor on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 35 is a schematic view of another preferred embodiment of thepresent invention using spectral reflectance.

FIG. 36 is a schematic view of a person showing another preferredembodiment in accordance with the present invention using spectraltransmission.

FIG. 37 is a schematic cross-sectional view of another preferredembodiment of the present invention using thermal emission.

FIG. 38 is a side perspective view of an alternative embodiment usinghead mounted gear as a support structure.

FIG. 39 is a schematic diagram of a preferred embodiment for generatingthermoelectric energy to power the sensing system.

FIG. 40 is a perspective view of a preferred embodiment for animal use.

FIGS. 41A and 41B are perspective views of an alternative embodiment ofa portable support structure with a sensor positioned at the tunnel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing a preferred embodiment of the invention illustrated in thedrawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents which operate in asimilar manner to accomplish a similar purpose.

FIG. 1A shows a thermal infrared image of the human face showing aphysiologic tunnel. The figure shows an image of the end of the braintemperature tunnel (BTT) depicted as white bright spots in the medialcanthal area and the medial half of the upper eyelid. The end of the BTTon the skin has special geometry, borders, and internal areas and themain entry point is located on the supero-medial aspect of the medialcanthal area diametrically in position with the inferior portion of theupper eyelid and 4 mm medial to the medial corner of the eye. From therethe boundary goes down in the medial canthal area diametrically inposition with the medial corner of the eye and within 5 mm down from themedial corner of the eye, and proceeding up to the upper eyelid with thelateral boundary beginning at the mid-part of the upper eyelid as anarrow area and extending laterally in a fan-like shape with thesuperior boundary beginning in the mid-half of the upper eyelid.

The scale indicates the range of temperature found in the human face.The hottest spots are indicated by the brightest white spots and thecoldest areas are black, temperature between the hottest and coldestareas are seen in different hues in a gray scale. The nose is cold (seenas black) since it is primarily composed of cartilage and bones, andconsequently has a lower blood volume. That is the reason why frostbiteis most common in the nose.

The surrounding periocular area of the upper and lower eyelids (seen asgray) is hotter because of high vascularization and the reduced amountof adipose tissue. The skin underneath the eyelids is very thin and doesnot have adipose tissue either. However, the other conditions necessaryto define a brain temperature tunnel are not present in this area.

The BTT requirements also include the presence of a terminal branch todeliver the total amount of heat, a terminal branch that is a directbranch from a vessel from the brain, a terminal branch that issuperficially located to avoid far-infrared radiation absorption byother structures, and no thermoregulatory arteriovenous shunts. Thus,the BTT, i.e., the skin area in the medial corner of the eye and uppereyelid, is the unique location that can access a brain temperaturetunnel. The skin around the eyelids delivers undisturbed signals forchemical measurements using spectroscopy and is defined as a metabolictunnel with optimal acquisition of signals for chemical evaluation, butnot for evaluation of the total radiant power of the brain.

FIG. 1B is a computer generated thermal infrared color plot image of thehuman face showing in detail the geometry and different areas of thebrain temperature tunnel and surrounding areas. Only few creatures suchas some beetles and rattle snakes can see this type of radiation, butnot humans. The infrared images make the invisible into visible. Thusthe geometry and size of the tunnel can be better quantified. The colorplot of the isothermal lines show the peripheral area of the tunnel inred and the central area in yellow-white with the main entry point atthe end of the BTT located in the supero-medial aspect of the medialcanthal area above the medial canthal tendon.

The main entry point is the area of most optimal signal acquisition. Theimage also shows the symmetry of thermal energy between the two BTTsites. Since other areas including the forehead do not have theaforementioned six characteristics needed to define a BTT, said areashave lower total radiant power seen as light and dark green. Thus theforehead is not suitable to measure total radiant power. The whole nosehas very little radiant power seen as blue and purple areas, and the tipof the nose seen as brown has the lowest temperature of the face. Thus,the nose area is not suitable for measuring biological parameters.

FIG. 2A is a schematic diagram of a physiologic tunnel, moreparticularly a Brain Temperature Tunnel. From a physical standpoint, theBTT is a brain thermal energy tunnel characterized by a high totalradiant power and high heat flow and can be characterized as a BrainThermal Energy tunnel. The tunnel stores thermal energy and provides anundisturbed path for conveying thermal energy from one end of the tunnelin the cavernous sinus inside of the brain to the opposite end on theskin with the thermal energy transferred to the surface of the skin atthe end of the tunnel in the form of far-infrared radiation. High heatflow occurs at the end of tunnel which is characterized by a thininterface, and the heat flow is inversely proportional to the thicknessof the interface.

The total radiated power (P) at the end of the tunnel is defined byP=σ*e*A*T⁴, where σ is the Stefan-Boltzman constant with a valueσ=5.67×10⁻⁸ W·m⁻²·K⁻⁴ and e is the emissivity of the area. Since the endof the tunnel provides an optimal area for radiation, the total powerradiated grows rapidly as the temperature of the brain increases becauseof the T⁴ term in the equation. As demonstrated in the experiments inthe present invention mentioned, the radiated power in the BTT occurredat a faster rate than the radiated power in the tongue and oral cavity.

The BTT site on the skin is a very small area measuring only less than0.5% of the body surface area. However, this very small skin region ofthe body provides the area for the optimal signal acquisition formeasuring both physical and chemical parameters.

FIG. 2A shows the brain 10 with the thermal energy 12 stored in itsbody. The BTT 20 include the brain 10, the thermal energy stored in thebrain 12, the thermal energy stored in the tunnel 14 and the thermalenergy 16 transferred to the exterior at the end of the tunnel. Thethermal energy 12, 14, 16 is represented by dark arrows of same size andshape. The arrows have the same size indicating undisturbed thermalenergy from one end of the tunnel to the other and characterized byequivalent temperature within the tunnel.

Thermal energy from the sinus cavernous in the brain 10 is transferredto the end of the tunnel 16 and a rapid rate of heat transfer occursthrough the unimpeded cerebral venous blood path. The tunnel also has awall 18 representing the wall of the vasculature storing the thermalenergy with equivalent temperature and serving as a conduit from theinside of the body 10 to the exterior (skin surface) 19 which ends as aterminal vessel 17 transferring the total amount of thermal energy tosaid skin 19.

The skin 19 is very thin and allows high heat flow. The thickness ofskin 19 is negligible compared to the skin 39, 49 in non-tunnel areas 30and 40 respectively. Due to the characteristics of skin 19, high heatflow occurs and thermal equilibrium is achieved rapidly when a sensor isplaced on the skin 19 at the end of the BTT 20.

In other areas of skin in the face and in the body in general, and inthe exemplary non-tunnel areas 30 and 40 of FIG. 2 several interferingphenomena occur besides the lack of direct vasculature connection to thebrain, and includes self-absorption and thermal gradient. 1.Self-absorption: This relates to the phenomena that deep layers oftissue selectively absorb wavelengths of infrared energy prior toemission at the surface. The amount and type of infrared energyself-absorbed is unknown. At the surface those preferred emissions areweak due to self-absorption by the other layers deriving disorderedthermal emission and insignificant spectral characteristic of thesubstance being analyzed being illustratively represented by the varioussize, shapes and orientations of arrows 34 a to 36 g and 44 a to 46 g ofFIG. 2. Self-absorption in non-tunnel areas thus naturally preventsuseful thermal emission for measurement to be delivered at the surface.2. Thermal gradient: there is a thermal gradient with the deeper layersbeing warmer than the superficial layers, illustratively represented bythicker arrows 36 d and 46 d in the deeper layers compared to thinnerarrows 36 e and 46 e located more superficially. There is excessive andhighly variable scattering of photons when passing through variouslayers such as fat and other tissues such as muscles leading to thermalloss.

Contrary to that, the tunnel area 20 is homogeneous with no absorptionof infrared energy and the blood vessels are located on the surface.This allows undisturbed delivery of infrared energy to the surface ofthe skin 19 and to a temperature detector such as an infrared detectorplaced in apposition to said skin 19. In the BTT area there is nothermal gradient since there is only a thin layer of tissue 19 withterminal blood vessel 17 directly underneath said thin interface skin19. The thermal energy 16 generated by the terminal blood vessel 17exiting to the surface skin 19 corresponds to the undisturbed brain(true core) temperature of the body. The preferred path for achievingthermal equilibrium with brain tissue temperature is through the centralvenous system which exits the brain and enters the orbit as the superiorophthalmic vein. The arterial blood is 0.2 to 0.3 degrees Celsius lowerwhen compared to the central venous blood, and said arterial blood isnot the actual equivalent of the brain temperature. Thus althougharterial blood may be of interest in certain occasions, the venoussystem is the preferred carrier of thermal energy for measurement ofbrain temperature. Arterial blood temperature may be of interest todetermine possible brain cooling by the arterial blood in certaincircumstances.

Non-tunnel areas 30 and 40 are characterized by the presence of heatabsorbing elements. The non-tunnel areas 30 and 40 are defined by brokenlines characterizing the vulnerability of interference by heat absorbingconstituents and by the disorganized transferring of heat in saidnon-tunnel areas 30 and 40. Various layers and other constituents innon-tunnel areas 30 and 40 selectively absorb infrared energy emitted bythe deeper layers before said energy reaches the surface of skin, andthe different thermal energy and the different areas are represented bythe different shapes and sizes of arrows and arrows heads.

Non-tunnel area 30 can be representative of measuring temperature with asensor on top of the skin anatomically located above the heart 32. Whitearrows 34 represent the thermal energy in the heart 32. Non-tunnel area30 includes the heart 32 and the various blood vessels and its branches36 a, 36 b, 36 c, 36 d storing thermal energy.

Different amounts of heat are transferred and different temperaturesmeasured depending on the location and anatomy of blood vessels 36 a, 36b, 36 c. The blood vessels branch out extensively from the main trunk 34a. The non-tunnel area 30 also includes heat absorbing structures 37such as bone and muscles which thermal energy 34 from the heart 32 needto be traversed to reach the skin 39. The non-tunnel area 30 alsoincludes a variable layer of fat tissue 38 which further absorbs thermalenergy. The reduced amount of thermal energy reaching the skin surface39 due to the presence of fat 38 is represented by the arrows 36 d and36 e, in which arrow 36 d has higher temperature than arrow 36 e.Non-tunnel area 30 also includes a thick skin 39 with low heat flowrepresented by arrows 36 f.

The thick skin 39 corresponds to the skin in the chest area and fatlayer 38 corresponds to the variable amount of fat present in the chestarea. Arrows 36 g represent the disordered and reduced total radiantpower delivered after said thermal energy traverses the interferingconstituents in the non-tunnel area including a thick interface and heatabsorbing structures. In addition, BTT 20 has no fat layer as found innon-tunnel areas 30 and 40. Lack of a thick interface such as thick skinand fat, lack of thermal barriers such as fat, and lack of heatabsorbing elements such as muscles allows undisturbed emission ofradiation at the end of the BTT. Lack of a thick interface such as thickskin and fat, lack of thermal barriers such as fat, and lack of heatabsorbing elements such as muscles allowed undisturbed emission ofradiation at the end of the BTT.

Yet referring to FIG. 2, non-tunnel area 40 can be representative ofmeasuring temperature with a sensor on top of the skin in the arm 42.The heat transfer in non-tunnel area 40 has some similarity withnon-tunnel area 30 in which the end result is a disordered and reducedtotal radiant power not representative of the temperature at theopposite end internally. The blood vessels branch out extensively fromthe main trunk 44 a. Thermal energy and temperature in blood vessels 46a, 46 b, 46 c is different than in areas 36 a, 36 b, 36 c. Thestructures that thermal energy 44 needs to traverse to reach the skinare also different compared to non-tunnel 30. The amount of heatabsorbing structures 47 is different and thus the end temperature atnon-tunnel 40 is also different when compared to non-tunnel area 30. Theamount of fat 48 also varies which changes the energy in areas area 46 dand 46 e, wherein 46 d is deeper than area 46 e. Thick skin 49 alsoreduces heat flow and the temperature of the area 46 f. Reduction ofradiant power indicated by arrow 46 g when compared to radiant power 36g is usually quite different, so different skin temperature is measureddepending on the area of the body. This applies to the whole skinsurface of the body, with the exception of the skin at the end of theBTT.

Measurements of internal temperature such as rectal do not have the sameclinical relevance as measurement in the brain. Selective brain coolinghas been demonstrated in a number of mammalian species under laboratoryconditions and the same process could occur in humans. For instance thetemperature in bladder and rectum may be quite different than the brain.High or low temperature in the brain may not be reflected in thetemperature measured in other internal organs.

FIG. 2B is a cross-sectional schematic diagram of the human head 9showing the brain 10, spinal cord 10 a, the tunnel 20 represented by thesuperior ophthalmic vein, the cavernous sinus 1, which is the thermalenergy storage compartment for the brain, and the various insulatingbarriers 2, 2 a, 3, 4, 4 a, 4 b, 5 that keep the brain as a completelythermally insulated structure. Insulating barriers include skin 2corresponding to the scalp, skin 2 a corresponding to the skin coveringthe face, fat 3 covering the whole surface of the skull and face, skullbone 4, spinal bone 4 a surrounding spinal cord 10 a, facial bone 4 bcovering the face, and cerebral spinal fluid (CSF) 5. The combinedthickness of barriers 2,3,4,5 insulating the brain can reach 1.5 cm to2.0 cm, which is a notable thickness and the largest single barrieragainst the environment in the whole body. Due to this completelyconfined environment the brain cannot remove heat efficiently and heatloss occurs at a very lower rate. Skin 2 corresponds to the scalp whichis the skin and associated structure covering the skull and which haslow thermal conductivity and works as an insulator. Fat tissue 3 absorbsthe majority of the far-infrared wavelength and works as a thermalbuffer. Skull bone 4 has low thermal conductivity and the CSF works as aphysical buffer and has zero heat production.

The heat generated by metabolic rate in the brain corresponds to 20% ofthe total heat produced by the body and this enormous amount of heat iskept in a confined and thermally sealed space. Brain tissue is the mostsusceptible tissue to thermal energy induced damage, both high and lowlevels of thermal energy. Because of the thermal insulation and physicalinability of the brain to gain heat or lose heat, both hypothermic(cold) and hyperthermic (hot) states can lead to brain damage and deathcan rapidly ensue, as occur to thousands of healthy people annuallybesides seizures and death due to high fever in sick people. Unlessappropriate and timely warning is provided by continuously monitoringbrain temperature anyone affected by cold or hot disturbances is at riskof thermal induced damage to the brain.

FIG. 2B also shows a notably small entry point 20 a measuring less than0.5% of the body surface which corresponds to the end of the tunnel 20on the skin 2 b. The skin 2 b is extremely thin with a thickness of 1 mmor less compared to the skin 2 and 2 a which are five fold or more,thicker than skin 2 b.

The tunnel 20 starts at the cavernous sinus 1 which is a conduit forvenous drainage for the brain and for heat transfer at the end of thetunnel 20 as a radiant energy. Tunnel 20 provides an obstructed passageto the cavernous sinus 1, a structure located in the middle of thebrain, and which is in direct contact with the two sources of heat tothe brain: 1) thermal energy produced due to metabolic rate by the brainand carried by the venous system; and 2) thermal energy delivered by thearterial supply from the rest of the body to the brain. This directcontact arrangement is showed in detail in FIG. 2C, which is a coronalsection of FIG. 2B corresponding to the line marked “A”.

FIG. 2C is a coronal section through the cavernous sinus 1 which is acavity-like structure with multiple spaces 1 a filled with venous bloodfrom the veins 9 and from the superior ophthalmic vein 6. Cavernoussinus 1 collects thermal energy from brain tissue 7, from arterial bloodof the right and left internal carotid arteries 8 a, 8 b, and fromvenous blood from vein 9. All of the structures 7, 8 a, 8 b, 9 aredisposed along and in intimate contact with the cavernous sinus 1. Aparticular feature that makes the cavernous sinus 1 of the tunnel a veryuseful gauge for temperature disturbances is the intimate associationwith the carotid arteries 8 a, 8 b. The carotid arteries carry the bloodfrom the body, and the amount of thermal energy delivered to the brainby said vessels can lead to a state of hypothermia or hyperthermia. Forinstance during exposure to cold, the body is cold and cold blood fromthe body is carried to the brain by internal carotid arteries 8 a, 8 b,and the cavernous sinus 1 is the entry point of those vessels 8 a, 8 bto the brain.

As soon as cold blood reaches the cavernous sinus 1 the correspondingthermal energy state is transferred to the tunnel and to the skinsurface at the end of the tunnel, providing therefore an immediate alerteven before the cold blood is distributed throughout the brain. The sameapplies to hot blood for instance generated during exercise which canlead to a 20 fold heat production compared to baseline. This heatcarried by vessels 8 a, 8 b is transferred to the cavernous sinus 1 andcan be measured at the end of the tunnel. In addition, the thermalenergy generated by the brain is carried by cerebral venous blood andthe cavernous sinus 1 is a structure filled with venous blood.

FIG. 3A is a thermal infrared image of the human face in which thegeometry of the end of the tunnel on the skin can be visualized. Thewhite bright spots define the central area of the tunnel. FIG. 3B is aschematic diagram of an exemplary geometry on the skin surface at theend of the tunnel. The medial aspect 52 of the tunnel 50 has a roundshape. The lateral aspect 54 borders the upper lid margin 58 andcaruncle 56 of the eye 60. The tunnel extends from the medial canthalarea 52 into the upper eyelid 62 in a horn like projection.

The internal areas of the tunnel 50 include the general area for themain entry point and the main entry point as shown in FIGS. 4A to 5D.FIG. 4A is a thermal infrared image of the side of the human faceshowing a general view of the main entry point of the brain temperaturetunnel, seen as white bright points located medial and above the medialcanthal corner. FIG. 4B is a diagram showing the general area 70 of themain entry point and its relationship to the eye 60, medial canthalcorner 61, eyebrow 64, and nose 66. The general area 70 of the mainentry point provides an area with more faithful reproduction of thebrain temperature since the area 70 has less interfering elements thanthe peripheral area of the tunnel.

FIG. 5A is a thermal infrared image of the front of the human face withthe right eye closed showing the main entry point of the braintemperature tunnel seen as white bright spots above and medial to themedial canthal corner. With closed eyes it is easy to observe that theradiant power is coming solely from the skin at the end of BTT.

FIG. SB is a diagram showing the main entry point 80 and itsrelationship to the medial canthal corner 61 of closed eye 60 andeyelids 62. The main entry point 80 of the tunnel provides the area withthe most faithful reproduction of the brain temperature since the area80 has the least amount of interfering elements and is universallypresent in all human beings at an equivalent anatomical position. Themain entry point 80 has the highest total radiant power and has asurface with high emissivity. The main entry point 80 is located on theskin in the superior aspect of the medial canthal area 63, in thesupero-medial aspect of the medial canthal corner 61.

FIG. 5C is a thermal infrared image of the side of the human face inFIG. 5A with the left eye closed showing a side view of the main entrypoint of the brain temperature tunnel, seen as bright white spots. Itcan be observed with closed eyes that the radiant power is coming solelyfrom the skin at the end of BTT.

FIG. 5D shows the main entry point 80 in the superior aspect of themedial canthal area above the medial canthal corner 61, and also showsthe position of main entry point 80 in relation to the eye 60, eyebrow64 and nose 66. Support structures can precisely position sensing meanson top of the main entry point of the tunnel because the main entrypoint is completely demarcated by anatomic landmarks. In general thesensor is positioned on the medial canthal skin area above the medialcanthal corner and adjacent to the eye. Although indicators can beplaced on support structures to better guide the positioning of thesensor, the universal presence of the various permanent anatomiclandmarks allows the precise positioning by any non-technical person.

The main entry point is the preferred location for the positioning ofthe sensor by the support structure, but the placement of a sensor inany part of the end of the tunnel including the general entry point areaand peripheral area provides clinically useful measurements depending onthe application. The degree of precision needed for the measurement willdetermine the positioning of the sensor. In cases of neurosurgery,cardiovascular surgery, or other surgical procedure in which the patientis at high risk of hypothermia or malignant hyperthermia, the preferredposition of the sensor is at the main entry point. For recreational orprofessional sports, military, workers, fever detection at home, wrinkleprotection in sunlight, and the like, positioning the sensor in any partof the end of the tunnel area provides the precision needed for clinicalusefulness.

In accordance with the present invention, FIG. 6 is a schematic view ofthe face showing the general area of the main entry point of the tunnel90 and the overall area of the end of the tunnel and its relationship tothe medial canthal tendon 67. The end of the tunnel includes the generalmain entry point area 90 and the upper eyelid area 94. The area 90 has aperipheral portion 92. Both medial canthal areas have a medial canthaltendon and the left eye is used to facilitate the illustration. Themedial canthal tendon 67 arises at the medial canthal corner 61 of eye60. The left medial canthal tendon 67 is diametrically opposed to theright medial canthal tendon as shown by broken lines 61 a which beginsat the medial corner of the eye 61. Although the main entry point isabove the medial canthal tendon 67, some of the peripheral area 92 ofthe tunnel is located below tendon 67.

FIG. 6A is a schematic diagram showing two physiologic tunnels. Theupper figure shows the area corresponding to the BTT 10. The lowerfigure shows an area corresponding to a metabolic tunnel 13 whichincludes the upper eyelid area 13 a and lower eyelid area 13 b seen aslight blue areas in FIG. 1B. For measuring the concentration of chemicalsubstances the total radiant power is not mandatory. The key aspect forclinical useful spectroscopic measurements is signal coming from thecerebral area and the reduction or elimination of interferingconstituents, and the main interfering constituent is adipose tissue. Byremoving adipose tissue and receiving spectral information carried by avasculature from the brain, precise and clinical measurements can beachieved. The sensors supported by support structure are adapted to havea field of view that matches in total or in part the metabolic tunnel 13for capturing thermal radiation from said tunnel 13.

To determine the thermal stability of the tunnel area in relation toenvironmental changes, cold and heat challenge tests were performed.FIGS. 7A and 7B are thermal infrared images of an exemplary experimentshowing the human face before and after cold challenge. In FIG. 7A theface has a lighter appearance when compared to FIG. 7B which is darkerindicating a lower temperature. The nose in FIG. 7A has an overallwhitish appearance as compared to the nose in FIG. 7B which has anoverall darker appearance. Since the areas outside the tunnel havethermoregulatory arteriovenous shunts and interfering constituentsincluding fat, the changes in the temperature of the environment arereflected in said areas. Thus measurements in those non-tunnel areas ofthe face reflect the environment instead of the actual body temperature.The non-tunnel areas of the skin in the face and body can change withthe changes in ambient temperature. The radiant power of the tunnel arearemains stable and there is no change in the amount of thermal energydemonstrating the stability of the thermal emission of the area. Changesof thermal radiation at the tunnel area only occur when the braintemperature changes, which provides the most reliable measurement of thethermal status of the body.

FIGS. 8A and 8B are thermal infrared images of the human face ofdifferent subjects showing the tunnel seen as bright white spots in themedial canthal area. The physiologic tunnel is universally present inall individuals despite anatomic variations and ethnic differences.FIGS. 9A and 9B are thermal infrared image showing that the tunnel seenas bright white spots are equally present in animals, illustrated hereby a cat (FIG. 9A) and a dog (FIG. 9B).

A preferred embodiment includes a temperature sensor with measurementprocessing electronics housed in a patch-like support structure whichpositions a passive sensor directly in contact with the skin over thebrain temperature tunnel site. Accordingly, FIG. 10 is a perspectiveview of a preferred embodiment showing a person 100 wearing a supportstructure comprised of a patch 72 with a passive sensor 74 positioned onthe skin at the end of the tunnel. Person 100 is laying on a mattress 76which contains antenna 78. Wire 82 extends from antenna 78 to controllerunit 84 with said controller 84 communicating with device 88 bycommunication line 86. Exemplary device 88 includes a decoding anddisplay unit at the bedside or at the nursing station. It is understoodthat controller unit 84 besides communicating by cable 86, can alsocontain wireless transmission means to wirelessly transmit the signalacquired to a remote station. This inductive radio frequency poweredtelemetry system can use the same antenna 78 to transfer energy and toreceive the signal.

The antenna 78 can be secured to a mattress, pillow, frame of a bed, andthe like in a removable or permanent manner. The preferred embodimentincludes a thin flat antenna encapsulated by a flexible polymer that issecured to a mattress and is not visible to the user. Alternatively anantenna can be placed in any area surrounding the patient, such as on anight stand.

The antenna 78 and controller unit 84 works as a receiver/interrogator.A receiver/interrogator antenna 78 causes RF energy to radiate to themicrocircuit in the patch 72. This energy would be stored and convertedfor use in the temperature measurement process and in the transmissionof the data from the patch 72 to the antenna 78. Once sufficient energyhas been transferred, the microcircuit makes the measurement andtransmits that data to the receiver/interrogator antenna 78 with saiddata being processed at controller 84 and further communicated to device88 for display or further transmission. The switching elements involvedin the acquisition of the sensor data (measurement of the energy) isdone in a sequence so that the quantized answer is available and storedprior to the activation of the noise-rich transmission signal. Thus thetwo inherently incompatible processes successfully coexist because theyare not active simultaneously.

The capability of the RF link to communicate in the presence of noise isaccomplished by “spreading” the spectral content of the transmittedenergy in a way that would inherently add redundancy to the transmissionwhile reducing the probability that the transmission can ever beinterpreted by the receiver/interrogator 78 as another transmission ornoise that would cause the receiver/interrogator 78 to transmit anddisplay incorrect information. This wireless transmission scheme can beimplemented with very few active elements. The modulation purposelyspreads the transmission energy across the spectrum and thus providesnoise immunity and the system can be ultimately be produced via batchprocessing and thus at a very low cost.

Since the energy to operate sensor 74 in patch 72 comes from the antenna78, the microcircuit in said patch 72 can be very small and ultra-thin.Size of the patch 72 would be further minimized to extremely smalldimensions by the design approach that places all the processingfunction of the RF link in the controller unit 84 working as a receiver.RF messaging protocol and the control of the sensor 74 resides in thereceiver/interrogator controller 84 powered by commercially availablebatteries or by AC current. Thus the RF messaging protocol and thecontrol of the sensor 74 is directly controlled by the MCU of controller84. The circuit resident in the patch 72 is preferably completelyself-contained. The sensing system 74 in the patch 72 is preferably asilicon microcircuit containing the circuits needed to support thesensor, quantatize the data from the sensor, encode the data for radiofrequency transmission, and transmit the data, besides powerconditioning circuits and digital state control. Sensor, supportcircuitry, RF power and communications are all deposited on a micro-chipdie allowing the circuit to be built in large quantities and at very lowcost. This scheme is preferably used for both passive and activedevices.

The operational process can consist of two modes, manual or automated.In the manual mode, an operator such as a nurse activates the system andRF energy radiated to the microcircuit in the patch 72 would be storedand converted for use in the temperature measurement process and in thetransmission of the data from the end of the BTT to the antenna 78. Oncesufficient energy has been transferred (less than 1 second) themicrocircuit would make the measurement and transmit the data to theantenna 78 receiver and controller 84 to be displayed for example on aback-lit LCD display at the nursing station. An audio “beep” will signalthat the data had been received and is ready for view. In the automatedmode, the process is done automatically and continuously byinterrogation at preset frequency and an alarm being activated when thereading is outside the specified range. A tri-dimensional antenna canalso be used and the controller 84 set up to search the three dimensionsof the antenna to assure continued and proper connection between antenna78 and sensing means 74. It is also understood that the sensor canmodulate reflected RF energy. Accordingly, the energy will trigger theunit to acquire a temperature measurement, and then the unit willmodulate the reflected energy. This reflected energy and informationwill be received at the interrogator and displayed as above.

The present invention also provides a method for monitoring biologicalparameters, which comprises the steps of: securing a passive sensor tothe body; generating electromagnetic radiation from a device secured toat least one of a mattress, a pillow and the frame of a bed; generatinga signal from said passive sensor; receiving said signal by a devicesecured to at least one of a mattress, a pillow and the frame of a bed;and determining the value of the biological parameter based on saidsignal.

It is understood that a variety of external power sources such aselectromagnetic coupling can be used including an ultra-capacitorcharged externally through electromagnetic induction coupling and cellsthat can be recharged by an external oscillator. It is also understoodthat the sensing system can be remotely driven by ultrasonic waves.

FIG. 11 is a perspective view of another preferred embodiment showing incloser detail a person 100 wearing a support structure comprised ofpatch 72 with a sensor 74, transmitter 71, and digital converter andcontrol 73 positioned on the skin at the end of the tunnel. Person 100is wearing a necklace which works as antenna 78 and a pendant in thenecklace works as the controller unit and transmitting unit 79. Solarcells and/or specialized batteries power unit 79. Patients are used tocarrying Holter monitoring and cards with cords around their necks andthis embodiment can fit well with those currently used systems. It isunderstood that, besides a necklace, a variety of articles includingclothing and electric devices can be used as a receiver/interrogator andthis capability can be easily incorporated into cell phones, note bookcomputers, hand held computers, internet appliances for connecting tothe internet, and the like, so a patient could use his/her cell phone orcomputer means to monitor his/her brain temperature.

The preferred embodiments shown in FIGS. 10 and 11 can preferablyprovide continuous monitoring of fever or temperature spikes for anysurgery, for any patient admitted to a hospital, for nursing homepatients, in ambulances, and to prevent death or harm by hospitalinfection. Hospital infection is an infection acquired during a hospitalstay. Hospital infection is the fourth cause of death in the US andkills more than 100,000 patients annually and occurs primarily due tolack of early identification of fever or temperature spikes. The presentinvention provides timely identification and therapy of an infection dueto 24 hour automated monitoring of temperature. If there is a spike intemperature an alarm can be activated. This will allow timelyidentification and treatment of an infection and thus prevent death orcostly complications such as septic shock that can occur due to delay intreating infectious processes. Besides, said preferred embodimentsprovide means for continuous fever monitoring at home including duringsleeping for both children and adults.

FIG. 12A is a front perspective view of a preferred embodiment showing aperson 100 wearing a support structure comprised of a patch 109 withindicator lines 111 and containing an active sensor 102 positioned onthe skin at the end of the tunnel. The preferred embodiment shown inFIG. 12 provides transmitting means 104, processing means 106, ADconverter 107 and sensing means 102 connected by flexible circuit 110 topower source 108. For example the transmitting module can include RF,sound or light. FIG. 12B is a side schematic view showing the flexiblenature of the support structure in FIG. 12A with flexible circuit 110connecting microelectronic package 103 which contains transmittingmeans, processing means and sensing means in the right side of the patch109 to the power source 108 in the left side of said patch 109.Exemplary embodiments will be described.

In accordance with this exemplary embodiment for temperaturemeasurement, the thermal energy emitted by the BTT is sensed by thetemperature sensor 102 such as a miniature thermistor which produces asignal representing the thermal energy sensed. The signal is thenconverted to digital information and processed by processor 106 usingstandard processing for determining the temperature. An exemplarysonic-based system for brain temperature measurement comprises atemperature sensor, input coupling circuit, signal processing circuit,output coupling circuit and output display circuit. A temperature sensor102 (e.g., thermistor) in a patch 109 placed on the surface of the skinat the medial canthal area responds to variations in brain temperaturewhich is manifested as a DC voltage signal.

This signal, coupled to a Signal Processor Circuit via an Input CouplingCircuit is used to modulate the output of an oscillator, e.g., amultivibrator circuit, piezoelectric systems operating in or just abovethe audio frequency range. The oscillator is a primary component of theSignal Processor Circuit. The output of the oscillator is input to anamplifier, which is the second primary component of the SignalProcessor.

The amplifier increases the output level from the oscillator so that theoutput of the Signal Processor is sufficient to drive an Output DisplayCircuit. Depending on the nature of the Output Display Circuit, e.g., anaudio speaker, a visual LED display, or other possible displayembodiment, an Output Coupling Circuit is utilized to match the signalfrom the Signal Processor Circuit to the Output Display Circuit. For anOutput Display Circuit that requires a digital input signal, the OutputCoupling Circuit might include an analog to digital (A/D) convertercircuit. A DC power supply circuit is the remaining primary component inthe Signal Processor Module. The DC power supply is required to supportthe operation of the oscillator and the amplifier in the SignalProcessing Circuit. Embodiments of the DC power supply can include ultraminiature DC batteries, a light sensitive DC power source, or somecombination of the two. The micro transducers, signal processingelectronics, transmitters and power source can be preferably constructedas an Application Specific Integrated Circuit or as a hybrid circuitalone or in combination with MEMS (micro electrical mechanical systems)technology.

The thermistor voltage is input to a microcontroller unit, i.e., asingle chip microprocessor, which is pre-programmed to process thethermistor voltage into a digital signal which corresponds to thepatient's measured temperature in degrees C. (or degrees F.) at the BTTsite. It is understood that different programming and schemes can beused. For example, the sensor voltage can be directly fed into to themicrocontroller for conversion to a temperature value and then displayedon a screen as a temperature value, e.g., 98.6° F. On the other hand thevoltage can be processed through an analog to digital converter (ADC)before it is input to the microcontroller.

The microcontroller output, after additional signal conditioning, servesas the driver for a piezoelectric audio frequency (ultrasonic)transmitter. The piezoelectric transmitter wirelessly sends digitalpulses that can be recognized by software in a clock radio sizedreceiver module consisting of a microphone, low-pass audio filter,amplifier, microcontroller unit, local temperature display andpre-selected temperature level alert mechanism. The signal processingsoftware is pre-programmed into the microcontroller unit of thereceiver. Although the present invention provides means for RFtransmission in the presence of noise, this particular embodiment usinga microphone as the receiving unit may offer additional advantages inthe hospital setting since there is zero RF interference with the manyother RF devices usually present in said setting. The microcontrollerunit drives a temperature display for each patient being monitored. Eachtransmitter is tagged with its own ID. Thus one receiver module can beused for various patients. A watch, cell phone, and the like adaptedwith a microphone can also work as the receiver module.

In another embodiment the output of the microcontroller is used to drivea piezo-electric buzzer. The microcontroller output drives thepiezo-electric buzzer to alert the user of the health threateningsituation. In this design the output of the microcontroller may be fedinto a digital-to-analog converter (DAC) that transforms the digitaldata signal from the microcontroller to an equivalent analog signalwhich is used to drive the buzzer.

In yet another embodiment the output from the (DAC) is used to drive aspeech synthesizer chip programmed to output an appropriate audiowarning to the user, for instance an athlete at risk of heatstroke. Fora sensed temperature above 39 degrees Celsius the message might be:“Your Body temperature is High. Seek shade. Drink cold liquid. Rest.”For temperature below 36 degrees Celsius the message might be: “YourBody temperature is Low. Seek shelter from the Cold. Drink warm liquid.Warm up.”

In another embodiment the output is used to drive a light transmitterprogrammed to output an appropriate light signal. The transmitterconsists of an infrared light that is activated when the temperaturereaches a certain level. The light signal will work as a remote controlunit that activates a remote unit that sounds an alarm. This embodimentfor instance can alert the parents during the night when the child issleeping and has a temperature spike.

An exemplary embodiment of the platform for local reporting consists ofthree electronic modules mechanically housed in a fabric or plasticholder such as patch 100, which contain a sensor 102 positioned on theskin at the BTT site. The modules are: Temperature Sensor Module,Microcontroller Module, and Output Display Module in addition to abattery. An electronic interface is used between each module for theoverall device to properly function. The configuration of this systemconsists of a strip such as patch 100 attached to the BTT area by aself-adhesive pad. A thermistor coupled to a microcontroller drives anaudio frequency piezoelectric transmitter or LED. The system provideslocal reporting of temperature without a receiver. An audio tone orlight will alert the user when certain thresholds are met. The tone canwork as a chime or reproduction of human voice.

Another exemplary embodiment for remote reporting consists of fourelectronic modules: Sensor Module, Microcontroller Module, OutputTransmitter Module and Receiver/Monitor Module. From a mechanicalviewpoint the first three modules are virtually identical to the firstembodiment. Electronically the Temperature Sensor and MicroprocessorModules are identical to the previous embodiment. In this embodiment anOutput Transmitter Module replaces the previous local Output DisplayModule. Output Transmitter Module is designed to transmit wirelessly thetemperature results determined by the Microprocessor Module to aremotely located Receiver/Monitor Module. An electronic interface isused between each module for proper function. This device can beutilized by patients in a hospital or home setting. On a continuousbasis temperature levels can be obtained by accessing data provided bythe Receiver/Monitor Module.

A variety of temperature sensing elements can be used as a temperaturesensor including a thermistor, thermocouple, or RTD (ResistanceTemperature Detector), platinum wire, surface mounted sensors,semiconductors, thermoelectric systems which measure surfacetemperature, optic fiber which fluoresces, bimetallic devices, liquidexpansion devices, and change-of-state devices, heat flux sensor,crystal thermometry and reversible temperature indicators includingliquid crystal Mylar sheets. Two preferred temperature sensors arethermistor models ET-503 and 104JT available from Semitec of Japan.

FIG. 13 shows a block diagram of a preferred embodiment of the presentinvention linking transmitter 120 to receiver 130. Transmitter 120preferably includes a chip 112 incorporating a microcontroller (MCU)114, a radio frequency transmitter (RF) 116 and a A/D converter 118 inaddition to a power source 122, amplifier (A) 124, sensor 126, andantenna 128, preferably built-in in the chip. Exemplary chips include:(1) rfPIC12F675F, (available from Microchip Corporation, Arizona, USA)this is a MCU+ADC+433 Mhz Transmitter (2) CC1010, available from ChipconCorporation of Norway.

Receiver 130 preferably includes a chip RF transceiver 132 (e.g., CC1000available from Chipcon Corporation), a microcontroller unit (MCU) 134,amplifier and filtering units (A/F) 136, display 138, clock 140, keypad142, LED 144, speaker 146, in addition to a power source 150 andinput/output units (I/O) 148 and associated modem 152, opticaltransceiver 154 and communication ports 156.

A variety of means can be used for the transmission scheme besides thecommercially available RF transmitter chips previously mentioned. Onesimple transmission means include an apparatus with a single channeltransmitter in the 916.48 MHz band that sends the temperature readingsto a bed side receiver as a frequency proportional to the reading. Thethermistor's resistance would control the frequency of an oscillatorfeeding the RF transmitter data input. If the duty cycle is less than1%, the 318 MHz band would be usable. Rather than frequency, a periodmeasurement technique can be used. The model uses a simple radiofrequency carrier as the information transport and modulating thatcarrier with the brain temperature information derived from atransduction device capable of changing its electrical characteristicsas a function of temperature (e.g.; thermistor). Either frequency oramplitude of the carrier would be modulated by the temperatureinformation so that a receiver tuned to that frequency could demodulatethe changing carrier and recover the slowly moving temperature data.

Another transmission technique suitable to transmit the signal from asensor in a support structure is a chirp device. This means that whenactivated, the transmitter outputs a carrier that starts at a lowerfrequency in the ISM band and smoothly increases frequency with timeuntil a maximum frequency is reached. The brain temperature informationis used to modify the rate of change of frequency of the chirp. Thereceiver is designed to measure the chirp input very accurately bylooking for two or more specific frequencies. When the first of thefrequencies is detected, a clock measures the elapsed time until thesecond frequency is received. Accordingly, a third, fourth, etc.,frequency could be added to aid in the rejection of noise. Sincevirtually all the direct sequence spread spectrum transmitters andfrequency hopping transmitters are spread randomly throughout their partof the ISM band, the probability of them actually producing the “right”sequence of frequencies at exactly the right time is remote.

Once the receiver measured the timing between the target frequencies,that time is the value that would represent the brain temperature. Ifthe expected second, third, or fourth frequency is not received by thereceiver within a “known” time window, the receiver rejects the initialinputs as noise. This provides a spread spectrum system by using a widespectrum for transmitting the information while encoding the informationin a way that is unlike the expected noise from other users of the ISMband. The chirp transmitter is low cost and simple to build and thebrain temperature transducer is one of the active elements that controlsthe rate of change of frequency.

Other preferred embodiments for local reporting include a sensor, anoperational amplifier (LM358 available from National SemicondutorCorporation) and a LED in addition to a power source. It is understoodthat the operational amplifier (Op Amp) can be substituted by a MCU andthe LED substituted by a piezoelectric component.

FIG. 14 is a schematic diagram showing the support structure 160 with asensor 158, and MCU 164 controlling and/or adjusting unit 162.Communication between MCU 164 and unit 162 is achieved by wires 168 orwirelessly 166. By way of example, but not by limitation, exemplaryunits 162 include climate control units in cars, thermostats, vehicleseats, furniture, exercise machines, clothing, footwear, medicaldevices, drug pumps, and the like. For example, MCU 164 is programmedwith transmit the temperature level to receiver unit 162 in the exercisemachine. MCU in the exercising machine unit 162 is programmed to adjustspeed or other settings in accordance with the signal generated by MCU164.

The preferred embodiment allows precise positioning of the sensingapparatus by the support structure on the BTT site. The supportstructure is designed to conform to the anatomical landmarks of the BTTarea which assures proper placement of the sensor at all times. Thecorner of the eye is considered a permanent anatomic landmark, i.e., itis present in the same location in all human beings. The BTT area isalso a permanent anatomic landmark as demonstrated by the presentinvention. To facilitate consistent placement at the BTT site, anindicator in the support structure can be used as shown in FIGS. 15A to15E.

FIG. 15A shows a Guiding Line 170 placed on the outside surface of thesupport structure 172. The Guiding Line 170 is lined up with the medialcorner of the eye 174. The sensor 176 is located above the Guiding Line170 and on the outer edge of the support structure 172, so once theGuiding Line 170 of the support structure 172 is lined up with themedial corner of the eye 174, the sensor 176 is positioned on the mainentry point of the tunnel. Thus the support structure 172 can beprecisely and consistently applied in a way to allow the sensor 176 tocover the BTT area at all times.

FIG. 15B shows a different design of the patch 172 but with the sameGuiding Line 170 lined up with the medial corner of the eye 174, thusallowing consistent placement of sensor 176 at the BTT site despite thedifference in design.

FIG. 15C is another preferred embodiment showing the sensor 176 lined upwith medial corner 174. Thus in this embodiment a Guiding Line is notrequired and the sensor 176 itself guides the positioning.

In FIG. 15D the MCU 175 and cell 177 of patch 172 are located outside ofthe BTT site while sensor 176 is precisely positioned at the BTT site.It is understood that any type of indicator on the support structure canbe used to allow proper placement in the BTT area including externalmarks, leaflets, cuts in the support structure, different geometry thatlines up with the corner of the eye, and the like.

FIG. 15E is another preferred embodiment showing the superior edge 176 aof sensor 176 lined up with medial corner 174 and located in theinferior aspect of the medial canthal area while microchip controller175 is located in the superior aspect of the medial canthal area.Support structure 172 has a geometric indicator 179 comprised of a smallrecess on the support structure 172. It is understood that a stripworking as support structure like a band-aid can have the side oppositeto the sensor and hardware made with tear off pieces. The sensor side isfirst attached to the skin and any excess strip can be easily torn off.Two sizes, adult and children cover all potential users.

The material for the support structure working as a patch can be softand have insulating properties such as are found in polyethylene.Depending on the application a multilayer structure of the patch caninclude from the external side to the skin side the following:thinsulate layer; double foam adhesive (polyethylene); sensor(thermistor); and a Mylar sheet. The sensor surface can be covered bythe Mylar sheet, which in turn is surrounded by the adhesive side of thefoam. Any soft thin material with high thermal resistance and lowthermal conductivity can be preferably used as an interface between thesensor and the exterior, such as polyurethane foam (K=0.02 W/m·C). Anysupport structure can incorporate the preferred insulation material.

A preferred power source for the patch includes natural thermoelectricsas disclosed by the present invention. In addition, standard lightweightthin plastic batteries using a combination of plastics such asfluorophenylthiophenes as electrodes can be used, and are flexibleallowing better conformation with the anatomy of the BTT site. Anotherexemplary suitable power source includes a light weight ultra-thin solidstate lithium battery comprised of a semisolid plastic electrolyte whichare about 300 microns thick.

The system can have two modes: at room temperature the system is quietand at body temperature the system is activated. The system can alsohave an on/off switch by creating a circuit using skin resistance, soonly when the sensor is placed on the skin is the system activated. Thepatch can also have a built-in switch in which peeling off a conductivebacking opens the circuit (pads) and turn the system on. In addition,when removed from the body, the patch can be placed in a case containinga magnet. The magnet in the case acts as an off switch and transmissionis terminated when said patch is in the case.

FIG. 16A to 16C are perspective views of preferred embodiments showing aperson 100 wearing support structures 180 incorporated as patches. In apreferred embodiment shown in FIG. 16A, the support structure 180contains LED 184, cell 186, and sensor 182. Sensor 182 is positioned ata main entry point on the superior aspect of the medial canthal areaadjacent to the medial corner of the eye 25. LED 184 is activated whensignal reaches certain thresholds and in accordance with the principlesof the invention. FIG. 16B is another preferred embodiment showing aperson 100 wearing support structure 180 with sensor 182 positioned atthe general area of the main entry point of the tunnel with the superioredge 181 of support structure 180 being lined up with the corner of theeye 25. Support structure 180 contains an extension that rests on thecheek area 189 and houses transmitting means 183 for wirelesstransmission, processing means 185 and power source 187. FIG. 16C is anexemplary preferred embodiment showing person 100 wearing a two piecestructure 180 a comprised of support structure 180 b and housingstructure 180 c connected by wires 192, preferably a flexible circuit.Support structure 180 b contains the sensor 182 which is positioned atthe BTT site. Housing structure 180 c which can comprise an adhesivestrip on the forehead 21 houses processing means 183 a, transmittingmeans 183 b and power source 187 for transmitting the signal to unit194, for example a cell phone.

FIG. 17 is a schematic view of another preferred embodiment showing thesupport structure 180 with sensor 182 being held at the nose 191 by aclip 196. Support structure 180 extends superiorly to the forehead 193.Housing 195 of support structure 180 contains pressure attachment meanssuch as clip 196. Housing 197 on the forehead contains the transmittingmeans and power source. Clip 196 uses a spring based structure 196 a toapply gentle pressure to secure support structure 180 and sensor 182 ina stable position. Housing 197 can also have a LCD display 19. The LCD19 can have an inverted image to be viewed in a mirror by the user,besides LCD 19 can have a hinge or be foldable to allow properpositioning to allow the user to easily view the numerical valuedisplayed.

FIG. 18 is a perspective view of another preferred embodiment showing aperson 100 wearing a support structure 180 comprised of a patch withsensor 182 positioned on the skin at the end of the tunnel and connectedby a wire 199 to a decoding and display unit 200. Support structure 180has a visible indicator 170 lined up with the medial corner of the eye174. Wire 199 includes an adhesive tape 201 within its first 20 cm, andmost preferably adhesive tape connected to wire 199 is in the first 10cm of wire from sensor 182.

FIGS. 19A1 to 19D are schematic views of preferred geometry anddimensions of support structures 180 and sensing means 182. Specialgeometry and dimension of sensors and support structure is necessary forthe optimal functioning of the present invention. The dimensions anddesign for the support structure 180 are made in order to optimizefunction and in accordance with the geometry and dimensions of thedifferent parts of the tunnel.

FIG. 19A1 shows support structure 180 working as a patch. The patch 180contains sensor 182. The patch 180 may contain other hardware or solelythe sensor 182. Exemplary sensor 182 is a flat thermistor or surfacemount thermistor. The preferred longest dimension for the patch referredto as “z” is equal or less than 12 mm, preferably equal or less than 8mm, and most preferably equal or less than 5 mm. The shortest distancefrom the outer edge of the sensor 182 to the outer edge of the patch 180is referred to as “x”. “x” is equal or less than 11 mm, preferably equalor less than 6 mm and most preferably equal or less than 2.5 mm. Forillustrative purposes the sensor 182 has unequal sides, and distance “y”corresponds to the longest distance from outer edge of the sensor toouter edge of the patch 180. Despite having unequal sides, the shortestdistance “x” is the determining factor for the preferred embodiment. Itis understood that the whole surface of the sensor 182 can be coveredwith an adhesive and thus there is no distance between the sensor and anouter edge of a support structure.

An exemplary embodiment for that includes a sensor in which the surfacetouching the skin at the BTT site is made with Mylar. The Mylar surface,which comprises the sensor itself, can have an adhesive in the surfacethat touches the skin.

As shown in FIG. 19A2, the sensor 182 has adhesive in its surface, to besecured to skin 11. The sensor then can be applied to the BTT site inaccordance with the principles of the invention. The preferred distance“x” equal or less than 2.5 mm allows precise pinpoint placement ofsensor 182 at the main entry site of the tunnel and thus allows the mostoptimal signal acquisition, and it should be used for applications thatrequire greatest precision of measurements such as during monitoringsurgical procedures. Although a patch was used as support structure forthe description of the preferred dimensions, it is understood that thesame dimensions can be applied to any support structure in accordancewith the principle of the invention including clips, medial canthalpads, head mounted gear, and the like.

FIG. 19B is an exemplary embodiment of a round patch 180 with a flatsensor 182. Preferred dimensions “x” and “z” apply equally as for FIG.19A1. FIG. 19C is an exemplary embodiment of a patch 180 with abead-type sensor 182. Preferred dimensions “x” and “z” apply equally asfor FIG. 19A1. FIG. 19D is an exemplary embodiment of a supportstructure 180 with a sensor-chip 15. Sensor chip 15 comprises a sensorthat is integrated as part of a chip, such as an Application SpecificIntegrated Circuit (ASIC). For example sensor chip 15 includes sensor 15a, processor 15 b, and transmitter 15 c. Preferred dimension “x” applyequally as for FIG. 19A1. Other hardware such as power source 27 may behoused in the support structure 180 which can have a long dimensionreferred to as “d” that does not affect performance as long as thedimension “x” is preserved.

The support structure and sensor are adapted to match the geometry anddimensions of the tunnel, for either contact measurements or non-contactmeasurements, in which the sensor does not touch the skin at the BTTsite.

FIGS. 20A to 20C show the preferred dimensions “x” for any supportstructure in accordance with the present invention. The distance fromthe outer edge 180 a of the support structure to outer edges of sensor182 a is 11 mm, as shown in FIG. 20A. Preferably, the distance from theouter edge 180 a of support structure to outer edges of sensor 182 a is6 mm, as shown in FIG. 20B. Most preferably, the distance from the outeredge 180 a of the support structure to outer edges of sensor 182 a is2.5 mm, as shown in FIG. 20C.

Preferred positions of sensors 182 in relation to the medial corner ofthe eye 184 are shown in FIGS. 21A and 21B. Support structure 180positions sensor 182 lined up with medial corner 184 (FIG. 21B).Preferably, as shown in FIG. 21A, support structure 180 positions thesensor 182 above the medial corner 184.

The preferred embodiments of support structures incorporated as patchesand clips are preferably used in the hospital setting and in the healthcare field including continuous monitoring of fever or temperaturespikes. Support structures incorporated as medial canthal pads or headmounted gear are preferred for monitoring hyperthermia, hypothermia andhydration status of recreational athletes, professional athletes,military, firefighters, construction workers and other physicallyintensive occupations, occupational safety, and for preventing wrinkleformation due to thermal damage by sun light.

FIGS. 22A to 22C are perspective views of preferred embodiments showinga person 100 wearing support structures incorporated as a medial canthalpad 204 of eyeglasses 206. In a preferred embodiment shown in FIG. 22A,the medial canthal pad 204 contains sensor 202. Connecting arm 208connects medial canthal pad 204 to eyeglasses frame 206 next to regularnose pads 212. Sensor 202 is positioned on the superior aspect of themedial canthal area adjacent to the medial corner of the eye 210.

FIG. 22B is an exemplary preferred embodiment showing person 100 wearingsupport structure incorporated as medial canthal pads 204 with sensor202 integrated into specially constructed eyeglasses frame 216 andcontaining LEDs 228, 230. Connecting piece 220 which connects the leftlens rim 222 and right lens rim 224 is constructed and positioned at ahigher position than customary eyeglasses construction in relation tothe lens rim 222, 224. Due to the higher position of connecting piece220 and the special construction of frame 216, the upper edge 222 a ofleft lens rim 222 is positioned slightly above the eyebrow 226. Thisconstruction allows medial canthal pad 204 to be positioned at the BTTsite while LEDs 228,230 are lined up with the visual axis. Arm 232 ofmedial canthal pad 204 can be flexible and adjustable for properpositioning of sensor 202 on the skin at the BTT site and for movingaway from the BTT site when measurement is not required. The LED 228 isgreen and LED 230 is red, and said LEDs 228, 230 are activated whensignal reaches certain thresholds.

FIG. 22C is an exemplary preferred embodiment showing person 100 wearingsupport structure incorporated as medial canthal pads 204 with sensor202. Signal from sensor 202 is transmitted wirelessly from transmitter234 housed in the temple of eyeglasses 236. Receiving unit 238 receivesa signal from transmitter 234 for processing and displaying. Exemplaryreceiving units 238 include watch, cell phone, pagers, hand heldcomputers, and the like.

FIGS. 23A to 23B are perspective views of alternative embodimentsshowing support structures incorporated as a modified nose pad 242 ofeyeglasses 244. FIG. 23A is a perspective view showing eyeglasses 244containing a modified nose pad 242 with sensor 240 and processor 241,sweat sensor 246 and power source 248 supported by temple 250, andtransmitter 252 supported by temple 254, all of which are electricallyconnected. Modified nose pads 242 are comprised of oversized nose padswith a horn like extension 243 superiorly which positions sensor 240 ontop of the end of the tunnel.

FIG. 23B is a perspective view showing eyeglasses 256 containing anoversized modified nose pad 258 with sensor 240, sweat sensor 260supported by temple 262, and transmitter 264 supported by temple 266.Modified oversized nose pad 258 measures preferably 12 mm or more in itssuperior aspect 258 a and contains sensor 240 in its outer edge inaccordance with the dimensions and principles of the present invention.

Another preferred embodiment of the invention, shown in FIG. 24,provides goggles 268 supporting medial canthal pads 260 adapted toposition sensor 262, 264 at the tunnel site on the skin. As shown,goggles 268 also support transmitting means 261, power source 263, localreporting means 265 such as LED and an antenna 267 for remote reporting.Antenna 267 is preferably integrated as part of the lens rim 269 ofgoggles 268.

As shown in FIG. 25, additional means related to the signal generated bysensor 270 in medial canthal pad 272 include power switch 274, setswitch 276 which denotes a mode selector, transmitter 278 for wirelesstransmission of signals, a speaker 282, piezoelectric device 283, inputmeans 284 and processing means 286. The means 274, 276, 278, 282, 284,and 286 are preferably supported by any portion of the frame ofeyeglasses 280. It is understood that a variety of means, switches andcontrolling means to allow storage of data, time and other multiplefunctions switches can be incorporated in the apparatus in addition towires for wired transmission of signals.

FIG. 26A is a rear perspective view of one preferred embodiment showingsensors 299, 300 supported by medial canthal pads 290, 289 of eyeglasses292 and includes lens rim 297 and display 298 in addition to transmitter288, sweat sensor 294 and wires 296 disposed within temple 295 and lensrim 293 of said eyeglasses 292 and connected to display means 296.

FIG. 26B is a front perspective view of eyeglasses 292 including sweatsensor 294, transmitter 288 and wires 296 disposed within temple 295 andlens rim 293 of eyeglasses 292 and connected to display means. In thisembodiment sweat sensor 294 produces a signal indicating theconcentration of substances in sweat (e.g., sodium of 9 mmol/L) which isdisplayed on left side display 296 and sensor 300 supported by medialcanthal pad 290 produces a signal indicative of, for example, braintemperature of 98 degrees F. which is displayed on the right sidedisplay 298. Sweat sensor can be porous or microporous in order tooptimize fluid passage to sensors when measuring chemical components.

A variety of display means and associated lenses for proper focusing canbe used including liquid crystal display, LEDs, fiber optic,micro-projection, plasma means, and the like. It is understood thatdisplay means can be attached directly to the lens or be an integralpart of the lens. It is also understood that display means can include aseparate portion contained in the lens rim or outside of the lens rim.Further, the two lenses and display 296, 298 held within the lens rims293, 297 can be replaced with a single unit which can be attacheddirectly to the frame of eyeglasses 292 with or without the use of lensrim 293, 297.

FIG. 27 is a perspective view of another preferred embodiment showing athree piece support structure 304 and preferably providing a medialcanthal pad connecting piece 303 adapted as an interchangeableconnecting piece. This embodiment comprises three pieces. Piece 301comprises left lens rim 301 a and left temple 301 b. Piece 302 comprisesright lens rim 302 a and right temple 302 b. Piece 303 called the medialcanthal piece connector comprises the connecting bridge of eyeglasses303 a and the pad structure 303 b of eyeglasses. Pad piece 303 isparticularly adapted to provide medial canthal pads 306 for positioninga sensor 308 at the BTT site. In reference to this embodiment, the usercan buy three piece eyeglasses in accordance with the invention in whichthe connector 303 has no sensing capabilities, and it is thus a lowercost. However, the three piece eyeglasses 304 offers the versatility ofreplacing the non-sensing connector 303 by a connector 303 with sensingcapabilities. As shown in FIG. 27 connector 303 with medial canthal pads306 and sensor 308 includes also radio frequency transmitter 310 andcell 312. Therefore, connector 303 provides all the necessary hardwareincluding means for sensing, transmitting, and reporting the signal. Anymeans for attachment known in the art can be used including pressuremeans, sliding means, pins, and the like.

Another preferred embodiment, as shown in FIG. 28A, provides a removablemedial canthal piece 314 supporting sensor 316. As shown, connectingbridge 320 of eyeglasses 318 are attached to medial canthal piece 314 ina releasable manner. Eyeglasses 318 further includes sweat sensor 322,324 supported by front part 311 and transmitting means 326 supported bytemple 313. Front part 311 of eyeglasses 318 defines a front browportion and extends across the forehead of the wearer and contains sweatsensor 322, 324. Sweat fluid goes through membranes in the sensor 322,324 and reaches an electrode with generation of current proportional tothe amount of analyte found in the sweat fluid.

FIG. 28B is a rear perspective view of the removable medial canthalpiece 314 showing visual reporting means 323, 325 such as a green LEDand a red LED in left arm 328 and sensor 316 adapted to be positioned atthe end of the tunnel, and wire 326 for electrically connecting rightarm 329 and left arm 328 of medial canthal piece 314. FIG. 28C is afront perspective view of the removable medial canthal piece 314 showingpower source 330, transmitter 332 and sensor 316 in right arm 329 andwire 326 for electrically connecting right arm 329 and left arm 328 ofmedial canthal piece 314. Medial canthal piece 314 can be replaced by anon-sensing regular nose pad which would have the same size anddimension as medial canthal piece 314 for adequate fitting withconnecting bridge 320 of eyeglasses 318 of FIG. 28A. The removablemedial canthal piece can have, besides LED, a built-in LCD display fordisplaying a numerical value and/or RF transmitter. Therefore, theremovable medial canthal piece can have one or various reporting meansintegrated as a single sensing and reporting unit.

FIG. 29 is a rear perspective view of one preferred embodiment of asupport structure incorporated as a clip-on 340 for eyeglasses andincludes attachment means 338 such as a hook or a magnet, transmittingmeans 342, processing means 344, power source 346, medial canthal pad348 mounted on a three axis rotatable structure 349 for properpositioning at the BTT site, and sensor 350. Clip-on 340 is adapted tobe mounted on regular eyeglasses and to fit the medial canthal pad 348above the regular nose pads of eyeglasses.

Sensing medial canthal pads can be preferably connected to attachmentstructure such as eyeglasses independent of the presence of specializedconnecting or attachment means mounted in said eyeglasses such asgrooves, pins, and the like. This embodiment provides means for theuniversal use of sensing medial canthal pads in any type or brand ofattachment structure. FIG. 30 shows a front perspective view of medialcanthal pads 352 comprising an adhesive backing 354 for securing pad 352to an attachment structure such as eyeglasses or another supportstructure. Adhesive surface 354 is adapted to match an area ofeyeglasses that allow securing medial canthal pad 352 to saideyeglasses, such as for instance the area corresponding to regular nosepads of eyeglasses. Medial canthal pad 352 works as a completelyindependent unit and contains sensor 356, power source 358 and reportingmeans 360 electrically connected by wire 361,362. Reporting means 360include local reporting with visual means (e.g., LED), audio means(e.g., piezoelectric, voice chip or speaker) and remote reporting withwireless transmission.

FIG. 31A is a top perspective view of one alternative embodiment of asupport structure incorporated as eyeglasses 380 with holes 364, 365 inregular nose pads 366, 376 for securing specialized medial canthal pads.Eyeglasses 380 includes wire 368 disposed within the right lens rim 371of the frame of eyeglasses 380 with said wire 368 connecting transmitter370 housed inside the right temple 369 to nose pad 366. Eyeglasses 380further includes wire 363 mounted on top of left lens rim 365 with saidwire 363 connecting transmitter 372 mounted on top of the left temple374 to nose pad 376. FIG. 31B is a magnified perspective view of part ofthe support structure 380 with hole 365 in regular nose pad 376. FIG.31C is a side perspective view of regular nose pad 366 with hole 364.FIG. 31D is a side perspective view of a medial canthal piece 382secured to hole 364 of regular nose pad 366.

FIG. 32A is a perspective view of a person 100 wearing a supportstructure comprised of medial canthal caps 390 secured on top of aregular nose pad 392 of eyeglasses 394. FIG. 32B is a perspective rearview of the medial canthal cap 390 showing sensor 396, transmitter chip398 and opening 397 for securing cap 390 to nose pads.

FIG. 33A is a perspective view of a medial canthal cap 390 being securedto the nose pad 392. Medial canthal cap 390 contains sensor 396,transmitter chip 398 and opening 397. FIG. 33B is a perspective viewshowing the end result of the medial canthal cap 390 secured to the nosepad 392.

Special nose pads are provided by the present invention for properpositioning a sensor at the BTT site. FIG. 34 is a perspective view of amodified left side rotatable nose pad 400 adapted to position a sensoron the skin at the end of the tunnel and includes nose pad 402 withsensor 401, arm 404, house 406 which houses a gear that allows rotationof a nose pad as a dial for positioning sensor 401 on different regionsof the tunnel identified as 1 and 2. Position 1 places the sensor inline with the medial canthal corner and reaches the general area of themain entry point of the tunnel and position 2 places the sensor abovethe medial canthal corner right at the main entry point of the tunnel.This embodiment allows automated activation of the sensing system andtakes advantage of the fact that the nose bridge is cold as seen in FIG.1 (nose is dark) and FIG. 2 (nose is purple and blue). When the pad isin its resting position (“zero”), the sensor 401 rests in a cold placewith temperature of 35.7° C. corresponding to the regular position ofnose pads on the nose. In position “zero” the sensor is in Sleep Mode(temperature of 35.8° C. or less). Changing the sensor to a hot regionsuch as the general area (position 1) or the main entry point (position2) automatically activates the sensor which goes into Active Mode andstart sensing function.

It is understood that numerous special nose pads and medial canthal padscan be used in accordance with the principles of the invention includinga pivotal hinge that allows pads to be foldable in total or in part,self-adjusting pads using a spring, pivoting, sliding in a groove, andthe like as well as self-adjusting mechanisms which are adaptable toanatomic variations found in different races. It is understood that themodified nose pads are preferably positioned high in the frame, mostpreferably by connecting to the upper part of the lens rim or within 6mm from the upper edge of the lens rim.

A variety of materials can be used including materials withsuper-adherent properties to allow intimate apposition of sensing meansto the BTT site. A variety of metallic wires exhibiting super-elasticproperties can be used as the hinge assembly mechanism for allowingproper positioning of sensing means to the BTT site. Medial canthal padscan be made of a flexible synthetic resin material such as a siliconrubber, conductive plastic, conductive elastomeric material, metal,pliable material, and the like so that appropriate apposition to the BTTsite at the medial canthal area and proper functioning is achieved. Itis also understood that the medial canthal pads can exhibit elastic andmoldable properties and include material which when stressed is able toremain in the stressed shape upon removal of the stress. Any type ofrubber, silicone, and the like with shape memory can also be used in themedial canthal pads and modified nose pad.

By greatly reducing or eliminating the interfering constituents andproviding a high signal to noise ratio with a sensor adapted to capturethermal radiation from the BTT, the present invention provide the meansneeded for accurate and precise measurement of biological parametersincluding chemical components in vivo using optical means such asinfrared spectroscopy. Moreover, the apparatus and methods of thepresent invention by enhancing the signal allows clinical usefulreadings to be obtained with various techniques and using differenttypes of electromagnetic radiation. Besides near-infrared spectroscopy,the present invention provides superior results and higher signal tonoise ratio when using other forms of electromagnetic radiation such asfor example mid-infrared radiation, radio wave impedance, photoacousticspectroscopy, Raman spectroscopy, visible spectroscopy, ultravioletspectroscopy, fluorescent spectroscopy, scattering spectroscopy andoptical rotation of polarized light as well as other techniques such asfluorescent (including Maillard reaction, light induced fluorescence andinduction of glucose fluorescence by ultraviolet light), colorimetric,refractive index, light reflection, thermal gradient, Attenuated TotalInternal Reflection, molecular imprinting, and the like. A sensoradapted to capture thermal energy at the BTE (Brain Thermal Energy)tunnel site provides optimal means for measurement of biologicalparameters using electromagnetic means. The BTE tunnel is the physicalequivalent to the physiologic BTT and is used herein to characterize thephysics of the tunnel. The geometry and dimension on the skin surfaceare the same for the BTT and BTE tunnel.

The following characteristics of the BTE tunnel allow optimal signalacquisition. Skin at the end of the BTE tunnel is thin. With a thickskin radiation may fail to penetrate and reach the substance to bemeasured. Skin at the BTE tunnel is homogenous with constant thicknessalong its entire surface. Random thickness of skin as occurs in otherskin areas prevent achieving the precision needed. The BTE tunnel has nofat. The intensity of the reflected or transmitted signal can varydrastically from patient to patient depending on the individual physicalcharacteristics such as the amount of fat. A blood vessel in the end ofthe BTE is superficial, terminal and void of thermoregulatory shunts. Inother parts of the skin the deep blood vessels are located deep and varygreatly in position and depth from person to person. The BTE tunnel hasno light scattering elements covering its end such as bone, cartilageand the like. Thermal radiation does not have to go through cartilage orbone to reach the substance to be measured. The end of the BTE tunnel onthe skin has a special but fixed geometry and is well demarcated bypermanent anatomic landmarks. In other skin surfaces of the body,inconsistency in the location of the source and detector can be animportant source of error and variability.

Far-infrared radiation spectroscopy measures natural thermal emissionsafter said emissions interact and are absorbed by the substance beingmeasured. The present invention provides a thermally stable medium,insignificant number of interfering constituents, and a thin skin is theonly structure to be traversed by the thermal emissions from the BTEtunnel before reaching the detector. Thus there is high accuracy andprecision when converting the thermal energy emitted by the BTE tunnelinto concentration of the substance being measured.

The natural spectral emission by BTE tunnel changes according to thepresence and concentration of chemical substances. The far-infraredthermal radiation emitted follow Planck's Law and the predicted amountof thermal radiation can be calculated. Reference intensity iscalculated by measuring thermal energy absorption outside the substanceof interest band. The thermal energy absorption in the band of substanceof interest can be determined via spectroscopic means by comparing themeasured and predicted values at the BTE tunnel site. The signal is thenconverted to concentration of the substance measured according to theamount of thermal energy absorbed.

A sensor adapted to view the BTE tunnel provides means for measuring asubstance of interest using natural brain far-infrared emissions emittedat the BTE tunnel site and for applying Beer-Lambert's law in-vivo.Spectral radiation of infrared energy from the surface of the BTE tunnelsite corresponds to spectral information of chemical substances. Thesethermal emissions irradiated at 38 degrees Celsius can include the 4,000to 14,000 nm wavelength range. For example, glucose strongly absorbslight around the 9,400 nm band. When far-infrared thermal radiation isemitted at the BTE tunnel site, glucose will absorb part of theradiation corresponding to its band of absorption. Absorption of thethermal energy by glucose bands is related in a linear fashion to bloodglucose concentration in the thermally sealed and thermally stableenvironment present in the BTE tunnel.

The support structure includes at least one radiation source frominfrared to visible light which interacts with the substance beingmeasured at the BTE tunnel and a detector for collecting the resultingradiation.

The present invention provides method for measuring biologicalparameters comprising the steps of measuring infrared thermal radiationat the BTE tunnel site, producing output electrical signalsrepresentative of the intensity of the radiation, converting theresulting input, and sending the converted input to a processor. Theprocessor is adapted to provide the necessary analysis of the signal todetermine the concentration of the substance measured and for displayingthe results.

The present invention includes means for directing preferablynear-infrared energy into the surface of the skin at the end of the BTEtunnel, means for analyzing and converting the reflectance or backscattered spectrum into the concentration of the substance measured andsupport means for positioning the light source and detector meansadjacent to the surface of the skin at the BTE tunnel site.

The present invention also provides methods for determining theconcentration of a substance with said methods including the steps ofdirecting electromagnetic radiation such as near-infrared at the skin atthe BTE tunnel site, detecting the near-infrared energy radiated fromsaid skin at the BTE tunnel site, taking the resulting spectra andproviding an electrical signal upon detection, processing the signal andreporting concentration of the substance of interest according to saidsignal. The invention also includes means and methods for positioningthe light sources and detectors in stable position and with stablepressure and temperature in relation to the surface to which radiationis directed to and received from.

The present invention further includes means for directing infraredenergy through the nose using medial canthal pads, means for positioningradiation source and detector diametrically opposed to each other, andmeans for analyzing and converting the transmitted resulting spectruminto the concentration of the substance measured. The present inventionalso provides methods for measuring biological parameters with saidmethods including the steps of directing electromagnetic radiation suchas near-infrared through the nose using medial canthal pads, collectingthe near-infrared energy radiated from said nose, taking the resultingspectra and providing an electrical signal upon detection, processingthe signal and reporting concentration of the substance measuredaccording to said signal. The invention also includes means and methodsfor positioning the radiation sources and detectors in a stable positionand with stable pressure and temperature in relation to the surface towhich radiation is directed through.

The present invention yet includes means for collecting naturalfar-infrared thermal radiation from the BTE tunnel, means forpositioning a radiation collector to receive said radiation, and meansfor converting the collected radiation from the BTE tunnel into theconcentration of the substance measured. The present invention alsoprovides methods for measuring biological parameters with said methodsincluding the steps of using the natural far-infrared thermal emissionfrom the BTE tunnel as the resulting radiation for measuring thesubstance of interest, collecting the resulting radiation spectra,providing an electrical signal upon detection, processing the signal andreporting the concentration of the substance measured according to saidsignal.

A drug dispensing system including an infusion pump can be activatedaccording to the level of the substance measured at the BTE tunnel, forexample insulin can be injected automatically as needed to normalizeglucose levels as an artificial pancreas.

Any substance present in blood which is capable of being analyzed byelectromagnetic means can be measured at the BTE tunnel. For example butnot by way of limitation such substances can include exogenous chemicalssuch as drugs and alcohol as well as endogenous chemicals such asglucose, oxygen, lactic acid, cholesterol, bicarbonate, hormones,glutamate, urea, fatty acids, triglycerides, proteins, creatinine,aminoacids and the like. Values such as pH can also be calculated as pHcan be related to light absorption using reflectance spectroscopy.

In accordance with FIG. 35 a schematic view of one preferred reflectancemeasuring apparatus of the present invention is shown. FIG. 35 shows alight source 420 such as an infrared LED and a photodetector 422 locatedside-by-side and disposed within support structure 426 such as a medialcanthal pad or modified nose pads of eyeglasses directing radiation 424at the BTE tunnel 430 with said light source 420 laying in apposition tothe skin 428 at the BTE tunnel 430. The light source 420 delivers theradiation 424 to the skin 428 at the BTE tunnel which is partiallyabsorbed according to the interaction with the substance 432 beingmeasured resulting in attenuated radiation 425. Part of the radiation424 is then absorbed by the substance 432 and the resulting radiation425 emitted from BTE tunnel 430 is collected by the photodetector 422and converted by a processor into the blood concentration of thesubstance 432. Thin skin 428 is the only tissue interposed betweenradiation 424, 425 and the substance 432 being measured. Theconcentration of the substance 432 is accomplished by detecting themagnitude of light attenuation collected which is caused by theabsorption signature of the substance being measured.

Infrared LEDs (wavelength-specific LEDs) are the preferred light sourcefor this embodiment because they can emit light of known intensity andwavelength, are very small in size, low-cost, and the light can beprecisely delivered to the site. The light source 420 emits preferablyat least one near-infrared wavelength, but alternatively a plurality ofdifferent wavelengths can be used. The light source emits radiation 424,preferably between 750 and 3000 nm, including a wavelength typical ofthe absorption spectrum for the substance 432 being measured. Thepreferred photodetector includes a semiconductor photodiode with a 400micron diameter photosensitive area coupled to an amplifier as anintegrated circuit.

FIG. 36 shows a schematic view of a person 100 wearing a supportstructure 434 and light source 436 and detector 438 adapted to measurebiological parameters using spectral transmission means. The lightsource 436 and photodetector 438 are positioned diametrically opposed toeach other so that the output of the radiation source 436 goes throughthe nasal interface 442 containing the substance 440 being measuredbefore being received by the detector 438. Photodetector 438 collectsthe resulting transmitted radiation which was directed through the nasalinterface 442. A variety of LEDs and optical fibers disposed within thesupport structure 434 such as the medial canthal pads, nose pads andframes of eyeglasses are preferably used as a light delivery for thelight source 436 and the light detector 438.

Arms of support structures 434 such as medial canthal pads are moveableand can be adjusted into different positions for creating fixed orchangeable optical path. Preferred substances measured include oxygenand glucose. The brain maintains constant blood flow, whereas flow inextremities change according to cardiac output and ambient conditions.The oxygen levels found in the physiologic tunnel reflects centraloxygenation. The oxygen monitoring in a physiologic tunnel isrepresentative of the general hemodynamic state of the body. Manycritical conditions such as sepsis (disseminated infection) or heartproblems which alter perfusion in most of the body can be monitored.Oxygen in the BTE tunnel can continuously monitor perfusion and detectearly hemodynamic changes.

FIG. 37 is a schematic cross-sectional view of another preferredembodiment of the present invention using thermal emission from the BTEtunnel. FIG. 37 shows a support structure 450 housing a thermal infrareddetector 444 which has a filter 446 and a sensing element 448 with saidsensing element 448 being preferably a thermopile and responding tothermal infrared radiation 452 naturally emitted by the BTE tunnel 454.The support structure 450 is adapted to have sensing means 448 with afield of view that corresponds to the geometry and dimension of the skin462 at the end of the BTE tunnel 454. Support structure 450 provideswalls 456, 458 which are in contact with the skin 462 with said wallscreating a cavity 460 which contains thermal radiation 453 which hasalready passed through thin skin 462.

For example in the thermally sealed and thermally stable environment inthe BTE tunnel 454, at 38° Celsius spectral radiation 453 emitted as9,400 nm band is absorbed by glucose in a linear fashion according tothe amount of the concentration of glucose due to thecarbon-oxygen-carbon bond in the pyrane ring present in the glucosemolecule. The resulting radiation 453 is the thermal emission 452 minusthe absorbed radiation by the substance 464. The resulting radiation 453enters the infrared detector 444 which generates an electrical signalcorresponding to the spectral characteristic and intensity of saidresulting radiation 453. The resulting radiation 453 is then convertedinto the concentration of the substance 464 according to the amount ofthermal energy absorbed in relation to the reference intensityabsorption outside the substance 464 band.

The same principles disclosed in the present invention can be used fornear-infrared transmission measurements as well as for continuous wavetissue oximeters, evaluation of hematocrit, blood cells and other bloodcomponents. The substance measured can be endogenous such as glucose orexogenous such as alcohol and drugs including photosensitizing drugs.

Numerous support structures can position sensors at the BTT site formeasuring biological parameters. Accordingly, FIG. 38 is a sideperspective view of an alternative embodiment showing a person 100 usinghead mounted gear 470 as a support structure positioning with wires 478and sensor 476 on the skin at the BTT site. A microelectronic package472 containing transmitting means, processing means, and power source isdisposed within or mounted on head band 470, with said head band 470providing wire 478 from microelectronic package 472 for connection withsensing means 476 on the skin at the BTT site.

It is understood that the sensing means can be an integral part of thesupport structure or be connected to any support structures such asusing conventional fasteners including screw, pins, a clip, atongue-groove relationship, interlocking pieces, direct attachment,adhesives, mechanical joining, and the like; and said support structuresinclude patches, clips, eyeglasses, head mounted gear, and the like.

Various means to provide electrical energy to the sensing system weredisclosed. The BTE tunnel offers yet a new way for natural generation ofelectrical energy. Accordingly, FIG. 39 is a schematic diagram of apreferred embodiment for generating thermoelectric energy from the BTEtunnel to power the sensing system. The generator of the inventionconverts heat from the tunnel into electricity needed to power thesystem. A thermoelectric module is integrated into the support structureto power the sensing system. The thermoelectric module preferablyincludes a thermopile or a thermocouple which comprises dissimilarmetallic wires forming a junction. As heat moves from the tunnel throughthe thermoelectric module an electric current is generated. Since theBTE tunnel is surrounded by cold regions, the Seebeck effect can providemeans for generating power by inducing electromotive force (emf) in thepresence of a temperature gradient due to distribution of electriccharges at the surface and interface of the thermoelectric circuitgenerated by the temperature at the BTE tunnel.

Accordingly, FIG. 39 shows the junctions T1 and T2 of metallic wire A470 and metallic wire B 472 kept at different temperatures by placingjunction T1 at the main entry point of the tunnel and junction T2 in acold area such as the nose bridge (denoted in blue or purple in FIG. 1B,and referred herein as blue-purple nose). Metallic wires A 470 and B 472are made of different materials and electric current flows from the hotto the cold region due to the thermal gradient with a magnitude given bythe ratio of the thermoelectric potential. The potential U is given byU=(Q_(a)−Q_(b))*(T₁−T₂), where Q_(a) and Q_(b) denote the Seebeckcoefficient (thermoelectric power) of metal A and metal B₂ and T₁denotes temperature at the entry point of the BTE tunnel and T₂ denotestemperature at the blue-purple nose. The thermoelectric potentialgenerated can power the sensing system and a capacitor 474 inserted intothe system can be used to collect and store the energy and MCU 476 isadapted to controls the delivery of energy as needed for measuring,processing and transmitting the signal.

It is understood that other means to convert thermal energy from the BTEtunnel into electricity can be used. It is also understood that thesurface of the eye and caruncle in the eye can provide a thermalgradient and Seebeck effect, however it is much less desirable thanusing the skin at the end of the BTE tunnel since hardware and wirestouching the surface of the eye and/or coming out of the eye can bequite uncomfortable and cause infection.

Contrary to that numerous support structures disclosed in the presentinvention including eyeglasses can easily be adapted to provide in anunobtrusive manner the power generating system of the invention, forexample by using a support structure such as eyeglasses for positioningthe hot junction at the BTE site using medial canthal pads andpositioning the cold junction on the nose using regular nose pads ofeyeglasses. It is also understood that although the power generatingsystem using Brain Thermal Energy was designed for powering the sensingsystem of the present invention, any other electrical device could beadapted to be supplied with energy derived from the Brain Thermal Energytunnel.

Additional embodiments include support structures to position the sensorat the BTT site of animals. Many useful applications can be achieved,including enhancing artificial insemination for mammalian species bydetecting moment of ovulation, monitoring herd health by continuousmonitoring of brain temperature, detection of parturition and the like.

Accordingly, FIG. 40 is a perspective view of a preferred embodimentshowing an animal 101 with sensor 480 positioned at the BTT site withwire 482 connecting sensor 480 with a microelectronic package 484containing transmitting means, processing means, and power source in theeyelid pocket 486 of animal 101. Signal from microelectronic package 484is preferably transmitted as radio waves 489. The signal from thetransmitter in package 484 can be conveyed to a GPS collar allowing theidentification of the animal having a high temperature associated withthe localization of said animal by GPS means. Whenever there is anincrease in brain temperature identified by the sensing means 480, thesignal of high temperature activates the GPS collar to provide thelocalization of the affected animal. Alternatively the remote radiostation receiving waves 489 activate the GPS system when the abnormalsignal is received. In this case, the transmitter in package 484 onlysends the signal to the remote station, but not to the GPS collar.

FIG. 41A is a perspective view of a portable support structure 490positioning sensor 492 in contact with the skin 494 at the BTT site formeasuring biological parameters. Support structure 490 incorporated as athermometer with a contact sensor 492 is held by a second person 17 forpositioning the sensor 492 on the skin 494 and performing themeasurement. FIG. 41B is a perspective view of a portable supportstructure 496 with walls 500 positioning non-contact sensor 498 such asa thermopile with a field of view that matches in total or in part thegeometry and dimension of the skin area at the end of the BTT. Supportstructure 496 incorporated as an infrared thermometer is held by asecond person 105 for positioning the sensor 498 and measuringbiological parameters. Although it is understood that pointing aninfrared detector to the BTT site can be used in accordance with theinvention, the temperature measured is not as clinically useful becauseof the ambient temperature. Therefore, the support structure 496contains walls 500 that create a confined environment for thermalradiation to reach sensor 498 from the skin over the tunnel. Walls 500of the support structure are adapted to match the geometry of the tunneland to provide a cavity 499 with the boundaries consisting of the sensorsurface 492 and the skin area 493 viewed by said sensor 498, in asimilar manner as described for FIG. 37.

It is also understood that many variations are evident to one ofordinary skill in the art and are within the scope of the invention. Forinstance, one can place a sensor on the skin at the BTT site andsubsequently place an adhesive tape on top of said sensor to secure thesensor in position at the BTT site. Thus in this embodiment the sensordoes not need to have an adhesive surface nor a support structurepermanently connected to said sensor.

It is understood that any electrochemical sensor, thermoelectric sensor,acoustic sensor, piezoelectric sensor, optical sensor, and the like canbe supported by the support structure for measuring biologicalparameters in accordance with the principles of the invention. It isunderstood that sensors using amperometric, potentiometric,conductometric, gravimetric, impedimetric, systems, and the like can beused in the apparatus of the invention for the measurement of biologicalparameters. It is also understood that other forms for biosensing can beused such as changes in ionic conductance, enthalpy, and mass as well asimmunobiointeractions and the like.

The foregoing description should be considered as illustrative only ofthe principles of the invention. Since numerous modifications andchanges will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and operationshown and described, and, accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

I claim:
 1. A support structure for use in measuring biologicalparameters in a brain temperature tunnel, said support structure beingmounted adjacent to the brain temperature tunnel, said support structurecomprising a body, said body including a nose piece for a pair ofeyeglasses, said nose piece including an extension having a temperaturesensor configured to measure temperature signals produced on the skin atan end of the brain temperature tunnel, and said body locating said nosepiece so that the extension is positioned adjacent to a medial corner ofan eye above a medial canthal tendon and in a medial third of an uppereyelid when said body is worn by an individual, said body including areporting device, said reporting device being configured to transmit asignal based upon a measurement by the sensor at the brain temperaturetunnel.
 2. The support structure as claimed in claim 1, wherein saidbody includes a visual display connected to the reporting device.
 3. Thesupport structure as claimed in claim 2, wherein said visual displayincludes a plurality of lights.
 4. The support structure as claimed inclaim 1, wherein said body includes a sweat sensor.
 5. The supportstructure as claimed in claim 4, wherein said sweat sensor includes anelectrode generating a current proportional to an amount of analytefound in fluid contacting the sweat sensor.
 6. The support structure asclaimed in claim 1, wherein said sensor is in a surface of said nosepiece.
 7. The support structure as claimed in claim 1, wherein said bodyincludes a power source and a transmitter.
 8. The support structure asclaimed in claim 1, wherein said reporting device includes a display fordisplaying a numerical value.
 9. The support structure as claimed inclaim 1, wherein said reporting device includes at least one of a visualdisplay, an audio display, and a remote reporting with a wirelesstransmitter.